SQA Regulatory Surveillance Summary for Q1 2025
By: Laurel Hacche and Debra Cortner
Agência Nacional de Vigilância Sanitária (ANVISA)
ANVISA Published Materials on New Rules for Post-Market Monitoring of Cosmetics, 23 January 2025
ANVISA has published the following documents to improve the safety of cosmetic products in Brazil and to support new rules for post-market monitoring of cosmetics and the implementation of new regulatory guidelines:
The Inspection Manual for professionals from the National Health Surveillance System (SNVS) offers clear and detailed guidelines for performing health inspections in the field of cosmetovigilance. Developed in collaboration with state and municipal health surveillance, the document aims to standardize inspection practices and ensure greater standardization in regulatory and health inspection activities.
The Questions and Answers on RDC 894/2024 were prepared based on inquiries from companies and associations in the cosmetic sector regarding the implementation of the new standard. This document aims to facilitate the understanding of the regulation and provide practical guidelines for its daily application, emphasizing the importance of collaboration between all actors involved in the production chain and use of cosmetic products.
Balance of the Operation for Safe Aesthetics: Six Clinics Prohibited, 14 February 2025
During the Aesthetics with Safety inspection, which was jointly performed by ANVISA and state and municipal health surveillance, six aesthetics and beautification services were completely prohibited; that is, their operations were suspended until further decision to the contrary. Such prohibition occurs when serious irregularities are found that cannot be remedied simply in the short term. More than 50 agents inspected 31 aesthetic establishments. Some level of irregularity was found in 30 of the inspected establishments; as a result, a sanitary administrative process of determination will be opened and penalties applied.
Several problems related to the absence of best practices in the operation of services in all states were detected, including: the lack of procedures and protocols for patient safety; the absence of medical records, which makes it difficult to investigate in cases of adverse events; the lack of waste management plans; failures in cleaning and sterilization of equipment; and inadequate conditions, such as the absence of sinks and alcohol dispensers for hand hygiene. The choice of establishments was motivated by complaints received from users and the high number of advertisements sponsored by brands in traditional media or social networks, in the current context of increasing reports of serious adverse events that occurred in aesthetic clinics or following procedures.
China: National Medical Products Administration (NMPA)
On 02 January 2025, the NMPA released two appendices to the Good Manufacturing Practices (GMP) for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging, respectively. These appendices will come into effect on 01 January 2026. Before that date, manufacturers of pharmaceutical excipients and packaging materials must upgrade their facilities and enhance their Quality Management Systems to fully comply with the new requirements. Key requirements for pharmaceutical excipients and packaging manufacturers include the following:
- Establishing and strengthening Quality Management Systems
- Implementing Change Management Systems
- Supporting Marketing Authorization Holders (MAHs) in Quality Audits
Key requirements for MAHs include:
- Strict management of excipients and packaging materials
- Enhancing supplier audits
- Strengthening Quality Control and inspections
- Improving change management
China Deepens Comprehensive Reform to Strengthen Drug, Medical Device Regulation, 06 January 2025
China has issued a guideline on comprehensively deepening the reform of drug and medical device regulation to promote the high-quality development of the pharmaceutical industry. The document, issued by the General Office of the State Council, aims to accelerate the construction of a unified national market and foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a pharmaceutical powerhouse. The guideline stipulates that by 2027, the legal and regulatory frameworks for drug and medical device supervision will be enhanced, while the quality and efficiency of review and approval processes for innovative drugs and devices will be significantly improved.
China Introduces Revised Medical Device Supervision and Administration Regulations, 22 January 2025
On 07 January 2025, the NMRA released the 2025 version of the Device Supervision and Administration Regulations, which replaces the 2017 version. The 2025 version includes revisions in general principles, registration and filing, production requirements, operations and use, adverse events monitoring and recalls, supervision and inspections, and legal responsibilities.
European Commission (EC)
Pilot Coordinated Assessment for Clinical Investigations and Performance Studies, 06 February 2025
Multiple member states, supported by the European Commission (EC), are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies in accordance with Articles 78 of the Regulation (EU) 2017/745 (MDR) and 74 of the Regulation (EU) 2017/746 (IVDR), respectively. This pilot will allow sponsors to submit a single application for pilot coordinated assessments, ensuring more harmonized interactions with member states approving clinical investigations or performance studies. By participating in the pilot for coordinated assessment, sponsors can benefit from the following:
- Unified engagement
- Increased transparency and harmonization
- Simplified requests for information
- Consistency across member states
- Efficiency in document management
- Simplified management of substantial modifications
- Faster overall processes
EC: Proposal for the Critical Medicines Act, 14 March 2025
The EC has proposed the Critical Medicines Act to improve the availability of essential medicines in the European Union (EU). The regulation aims to diversify supply chains, boost EU pharmaceutical production, and improve access to critical medicines. The Act responds to medicinal shortages caused by supply chain vulnerabilities, global competition, and manufacturing issues and aims to both make the EU more attractive for pharmaceutical production and to strengthen resilience. Key measures include the following:
- Strategic projects to expand or modernize EU manufacturing, supported by more efficient access to funding and streamlined regulations.
- State aid guidance to help member states finance these projects.
- Public procurement rules requiring diversified supply sources and incentives for EU production.
- Collaborative procurement to improve availability of medicine across the EU.
- International partnerships to reduce dependence on limited suppliers.
The initiative complements EU pharmaceutical reform and the European Medicines Agency’s (EMA) expanded role in managing shortages, reinforcing the EU’s efforts to secure medicinal supply chains.
European Medicines Agency (EMA)
The EMA’s Guideline on Quality, Non-clinical, and Clinical Requirements for Investigational Advanced Therapy Medicinal Products (ATMPs) in clinical trials provides comprehensive guidance on the structure and data requirements for clinical trials of ATMPs, including gene therapy products, cell-based therapies, and tissue-engineered products. It covers manufacturing, quality control, non-clinical, and clinical development phases, with a particular focus on the requirements for exploratory studies, including first-in-human studies and confirmatory studies.
The guideline emphasizes the need for detailed quality documentation for ATMPs and includes information on the manufacture of the active substance, such as the manufacturing process, control of materials, and process validation. Particular attention is paid to the characterization of the Active Pharmaceutical Ingredient (API) so that its structure and properties may be fully understood. Specifications and analytical methods for the quality control of the API are also required.
EMA Network Strategy for 2028, 18 March 2025
The EMA Network Strategy for 2028 equips the European medicines regulatory network to respond to change and address challenges such as public health emergencies and threats, including antimicrobial resistance. It focuses on the following six areas:
- Accessibility – facilitating access to medicines in the EU
- Leveraging data, digitalization, and Artificial Intelligence (AI) – improving decision-making, optimizing processes, and increasing efficiency
- Regulatory science, innovation, and competitiveness – helping improve innovation and competitiveness in the EU healthcare sector
- Antimicrobial resistance and other health threats – preparing the EU for potential threats, including antimicrobial resistance
- Availability and supply – strengthening availability of medicines to protect public and animal health
- Sustainability of the EMA network – ensuring available resources to support scientific and regulatory decision-making
The updated network strategy for 2028 builds on the strategy for 2025.
Health Canada
Non-Compliant Inspection Rating for TJP Labs Inc., 13 January 2025
TJP Labs Inc., located in Pickering, Ontario, received a non-compliant rating from a GMP domestic inspection on 13 January 2025. Key findings included the following observations:
- The company did not have adequate resources for maintenance of the Quality Management System (QMS).
- The Quality Control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
- Controls were inadequate for creating, modifying, reviewing, storing, and/or retrieval of records.
- The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
- The premises and/or the manufacturing process was inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.
Non-Compliance Inspection Rating for 6112419 Canada LTD. DBA Oxygene Medical Plus, 22 January 2025
6112419 Canada LTD. DBA Oxygene Medical Plus, an importer and distributor of medical devices, received a non-compliant rating from an inspection that began on 22 January 2025. The inspection was conducted at the company’s facility in Thetford Mines, Quebec. Key findings included the following observations:
- The written procedure for recalls was not implemented by the company.
- Devices not authorized for sale by Health Canada were sold by the company.
- Written procedures for distribution records and incident reporting were inadequate.
- The company did not have written procedures for handling, storing, delivering, installing, or servicing medical devices, contrary to what had been committed to on its establishment license application.
India
India’s central government has granted a one-year extension for small and medium-sized pharmaceutical units with an annual turnover of less than INR 2.5 billion (US $28.77 million) to comply with the revised Schedule M standards, which set quality benchmarks and Good Manufacturing Practices (GMP). In response to requests from small and medium manufacturers seeking additional time to upgrade infrastructure, train personnel, and secure financial resources, the Union Health Ministry announced the decision to extend the compliance deadline. These manufacturers must submit an upgrade plan in Form A to the Central License Approving Authority (CLAA) within three months of 11 February 2025. Form A refers to the official document that small and medium pharmaceutical manufacturers must submit to the designated authority to outline their plan for infrastructure upgrades, personnel training, and compliance with the new Schedule M standards. This form serves as a declaration of intent from manufacturers, detailing how they plan to meet the GMP and equipment requirements within the extended timeline.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances – Quality, Efficacy, Multidisciplinary, and Safety
The ICH E6 (R3) Guideline Reaches Step 4 of the ICH Process, 14 January 2025
The ICH E6 (R3) Good Clinical Practice Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. The guideline builds on key concepts outlined in ICH E8 (R1) General Considerations for Clinical Studies. ICH E6 (R3) is comprised of Principles and Annexes that expand on the principles, with specific details for different types of clinical trials. The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial. Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials.
ICH M13B Draft Guideline and Step 2 Presentation Now Available on the ICH Website, 14 March 2025
The ICH M13B draft guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver reached Step 2b of the ICH Process on 13 March 2025 and entered the public consultation period. A Step 2 Informational Presentation has also been developed by the M13B EWG. Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13B guideline is intended to provide recommendations on obtaining waivers of Bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. This guideline is applicable to both development and post-approval phases for orally administered Immediate-Release (IR) tablets, capsules, and granules/powders for oral suspension.
International Pharmaceutical Excipients Council (IPEC)
IPEC: Version 3 of GDP Guide Available, 13 February 2025
In January 2025, version 3 of the IPEC Good Distribution Practices Guide for Pharmaceutical Excipients was published on the IPEC website. The guide had been available to members in the IPEC member area since October 2024 and can now be viewed in the Resources section of the Guidelines area.
IPEC Federation Position Paper on Third Party Audit and Certification Programs, February 2025
The IPEC Federation has announced the availability of the updated position paper on third-party audit and certification programs. The position paper was first published in September 2015. The IPEC Federation believes that independent, third-party auditing and certification of excipient suppliers can assist in the development, manufacture, and supply of safe and effective medicinal products. The use of third-party audit and certification programs helps to reduce cost, time, and resources of excipient suppliers and users alike. Such third-party audit and certification schemes raise quality expectations to an industry-accepted level and enhance patient safety. The position paper can be downloaded from the Resources section of Position Papers area on the IPEC website.
Updated: IPEC Quality-by-Design Guide, 25 February 2025
The IPEC Federation announced the availability of the revised IPEC Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, version 2, 2025. The guide was first published as an IPEC Federation Guide in 2020; however, with this revision, the guide has been updated to include an annex incorporating contents from the IPEC-Americas QbD Sampling Guide. It is widely applicable on a global level.
Medicines and Healthcare Products Regulatory Agency (MHRA)
Criminal Denied £7.5 Million in Profits from the Illegal Trade in Medicines, 29 January 2025
The MHRA’s Criminal Enforcement Unit (CEU) leads efforts to disrupt medicine crime by denying criminals the profits that fuel it. Using its legislative powers, the CEU can freeze bank accounts, intercept digital currencies, seize luxury goods, and confiscate the proceeds of crime following conviction. In 2024, the CEU’s financial investigators denied these criminals access to a total of £7.5 million in criminal assets. Most of the seized medicines are not licensed for sale in the UK, so can contain too much or too little of the declared active ingredient. These medicines may also contain other ingredients that have not been approved for use. The CEU also continued to target individuals and networks illegally trading in medicines online, disrupting more than 1,500 websites and social media accounts illegally selling medicinal products.
The MHRA has issued a new guidance to help manufacturers meet UK medical device regulations and ensure digital mental health technologies are effective, reliable, and safe. From mental health apps, AI-powered assessments, and virtual reality therapy, digital mental health technologies are increasingly used by individuals and the National Health Service (NHS) to support mental health. Digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and safe, just like any other medical device. Manufacturers may be unsure how medical device regulations apply to software, which products are regulated, how they are assessed, and what evidence is required. The new guidance explains the following:
- How to define and communicate the intended purpose of digital mental health technologies.
- When a digital mental health technology is considered a medical device under UK law.
- How risk classification is determined, ensuring proportional regulation for different types of technologies.
The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. These products are manufactured by Suzhou Surgicare Medical Technology Ltd and distributed by HJ Medical (GyneVision). The CE certificate was withdrawn by the manufacturer’s Conformity Assessment Body due to concerns related to the manufacturer’s surveillance activities. The Surgicare Disposable Hysteroscopy Sheath is intended to be used as a single-use operative sheath used with the Flex-Eye HD hysteroscope, forming an integrated system designed to enable rapid diagnostic-to-therapeutic conversions during hysteroscopic procedures. The MHRA has safety concerns related to these products, such as the risk of infection and inappropriate sterilization procedures
Parenteral Drug Association (PDA)/American National Standards Institute (ANSI)
PDA Points to Consider No. 11 is focused on the use of viral vectors for delivery of a therapeutic gene, both in vivo and for ex vivo modification within the overall classification of Advanced Therapy Medical Products (ATMPs). The addressed topics are diverse and include plasmid and viral vector categorization and control, quality by design, control strategies, filtration, comparability, platform technologies, and potency assays. The topics are presented in a question-and-answer format: a specific problem statement is presented followed by an accompanying recommendation to assist the reader in formulating a strategy to address the topic.
PDA/ANSI Standard 03-2025 provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is applicable to aseptic processes used to manufacture sterile products, terminally sterilized products, and low bioburden processes in the manufacture of regulated healthcare products. It is applicable to pharmaceutical, biological, and ATMPs. This standard does not supersede or replace regulatory requirements such as current Good Manufacturing Practices (cGMPs) and/or compendial requirements that pertain to a particular national or regional jurisdiction.
ANSI evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. PDA/ANSI Standard 06-2025 identifies five key focus topics with attributes, characteristics, and measurements that should be considered to effectively establish, measure, and maintain a mature quality culture as an important fundamental element of a robust QMS. The five key focus topics were selected for their comprehensiveness from the PDA Quality Culture Assessment Tool.
Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
PIC/S Publishes Guidance Documents on Remote Assessment, 08 January 2025
PIC/S has published two guidance documents for inspectors: Guidance on Remote Assessments (PI 056-1) and Aide Memoire on Remote Assessments (PI 057-1), which were prepared by the PIC/S Working Group on Remote Assessment. PI 056-1 is intended to provide guidance on the approach and use of remote assessments, including hybrid inspections to establish consistency amongst inspectorates. It discusses the logistics for conducting remote assessments, including necessary technical aspects. PI 057-1 utilizes best practices to perform interactive remote assessments, including hybrid inspections to assist GMP inspectors in the lifecycle process of remote assessments.
Therapeutic Goods Administration (TGA)
Following an investigation by the Therapeutic Goods Administration (TGA), the Commonwealth Office of the Director of Public Prosecutions has laid 12 charges against an individual for alleged criminal offences under the 1989 Therapeutic Goods Act (the Act). The alleged offences relate to the advertising and supply of black salve, bloodroot capsules, and other unapproved therapeutic goods. The individual was alleged to make claims about the products’ ability to treat serious health conditions, including anxiety and cancer. The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge. The TGA strongly advises consumers against purchasing or using black salve or bloodroot capsules. There is no credible scientific evidence to substantiate the benefits of these products for the management of serious conditions.
Black salve and bloodroot capsules are derived from Sanguinaria canadensis (bloodroot), which contains sanguinarine, a substance included in Schedule 10 of the Poisons Standard. Schedule 10 substances are considered so dangerous to health that they are prohibited from sale, supply, and use in Australia. Black salve is a corrosive topical paste that causes burns, destroying layers of skin and surrounding healthy tissue. This may result in pain, scarring, ulceration, swelling, and infection. Bloodroot capsules may contain several of the same ingredients as black salve.
Nitrosamine and Nitroso-Structure Impurities Acceptable Intakes Update, 19 February 2025
The TGA has published updated information for nitrosamine impurities and other nitroso-structure impurities in medicines consistent with recent EMA updated information. The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the AI limit for some impurities, inclusion of recently internationally determined AI limits for numerous nitrosamine impurities, and other nitroso-structure impurities in medicines.
The TGA is introducing Unique Device Identification (UDI) over a five-year period with compliance for high-risk medical devices first, followed by lower risk devices in later years. This allows medical device sponsors or manufacturers to progressively prepare for and comply with UDI requirements. UDI requirements become mandatory on different dates, based on the risk class of the device or In Vitro Diagnostic (IVD). High-risk and implantable devices have earlier UDI compliance start dates, with medium- and lower-risk devices requiring UDI compliance in later years. The TGA is providing transition arrangements for devices that are:
- Manufactured and labelled prior to applicable compliance dates (known as existing devices)
- Supplied in Australia under an EU certificate
United States Food and Drug Administration (FDA) – Regulations and Guidances
The FDA is announcing the availability of a final guidance for industry entitled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes the FDA’s interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while the FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the FD&C Act. This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
The Draft Guidance for Industry and Staff, Artificial Intelligence – Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations provides recommendations regarding the contents of marketing submissions for devices that include AI-enabled device software functions, including documentation and information that will support the FDA’s evaluation of safety and effectiveness. The recommendations reflect a comprehensive approach to the management of risk throughout the device Total Product Life Cycle (TPLC). To support the development of appropriate documentation for the FDA’s assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout the TPLC.
Draft Guidance for Industry, Complying with 21 CFR 211.110, January 2025
The Draft Guidance for Industry, Complying with 21 CFR 211.100 describes considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. This guidance also discusses related quality considerations for drug products manufactured using advanced manufacturing and describes how manufacturers can incorporate process models into commercial manufacturing control strategies.
The Guidance for Lead in Processed Food presents the background and rationale for the FDA’s action levels for lead in processed food intended for babies and young children. Processed food in this guidance refers to packaged food (e.g., in jars, pouches, tubs, or boxes) represented or purported to be for babies and young children less than two years old. It may include ready-to-eat foods (e.g., purees) as well as semi-prepared foods (i.e., dry infant cereals). The action levels for processed foods intended for babies and young children are as follows:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
- 20 ppb for single-ingredient root vegetables
- 20 ppb for dry infant cereals
The FDA considers the action levels described in this guidance to be achievable by industry when control measures are taken to minimize the presence of lead. Although action levels are the levels at which the FDA may regard a food as adulterated, their Closer to Zero initiative outlines other actions they will take to further reduce lead (as well as other toxic elements) in food and expects that industry to strive for continual reductions over time.
United States Food and Drug Administration (FDA) – Recalls
The New York Wholesale Group of Hicksville, NY is recalling Zaarah Herbals Shatavari Powder to the consumer/user level because it has the potential to be contaminated with elevated levels of lead. Zaarah Herbals Shatavari Powder was distributed to retailers located in New York, New Jersey, Connecticut, and California between 21 October 2022 and 15 April 2024. The recall is the result of an analysis conducted by the Connecticut Department of Consumer Protection; the Food and Standards Division revealed the product contained elevated levels of lead. No illnesses have been reported to date.
Becton, Dickinson and Company (BD) has announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions, allowing the growth of Aspergillus penicillioides. The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the healthcare professional and then consequently the sterile field. Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissue. This lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue.
Central Admixture Pharmacy Services (CAPS) is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially block blood vessels in the heart, lungs, or brain, leading to serious complications such as stroke or even death. To date, CAPS has not received any reports of adverse events or injuries associated with this recall.
United States Food and Drug Administration (FDA) – Warning Letters
Robbins Instruments, LLC, Warning Letter, 21 January 2025
Robbins Instruments, LLC received a warning letter on 21 January 2025. This warning letter was the result of an FDA inspection conducted from 27 March 2024 to 31 May 2024 at the company’s facility in Houston, TX. It was determined that Robbins Instruments, LLC was marketing a Dermo-Jet Needleless Injector device without marketing clearance or approval. The device is also considered to be misbranded, because the company did not notify the FDA of its intent to introduce the device into commercial distribution. Specifically, the instructions for use document for the Dermo-Jet Needleless Injector included in the company’s Standard Operating Procedure (SOP) provided during the referenced inspection outlines the following indications: “The DERMO-JET is a versatile, time-tested, medical instrument for administration of sub-topical injections of parenteral medicaments, anesthetic solutions, steroids in aqueous suspension, soluble drugs, vaccines, antibiotics, etc.” The FDA has requested that Robbins Instruments, LLC cease any activities that result in the misbranding or adulteration of the Dermo-Jet Needleless Injector, including commercial distribution.
The FDA has issued warning letters to two India-based manufacturers of APIs Jagsonpal Pharmaceuticals Limited and Tyche Industries Ltd, citing significant violations of cGMPs that resulted in their products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters, issued on 05 February 2025 and 06 February 2025, respectively, detail serious compliance failures, including quality control lapses, data integrity issues, and the failure to ensure proper registration with the FDA.
Jagsonpal Pharmaceuticals, based in Rajasthan, was found to have inadequate oversight of its contract manufacturing operations. The FDA’s inspection revealed that the company failed to ensure that its CMO adhered to cGMP standards. Additionally, the company did not properly validate its manufacturing processes or verify that analytical methods used for drug testing were suitable for their intended use. The FDA also cited Jagsonpal for obstructing its inspection process by initially refusing entry to inspectors and later limiting access to requested documents. The agency placed the company’s products on Import Alert 66-40, effectively blocking them from entering the U.S. market.
Tyche Industries, located in Andhra Pradesh, was similarly flagged for cGMP violations, including falsification of manufacturing data. The FDA’s inspection revealed that company employees had manipulated temperature records for a drying oven used in drug production, leading to failures in product quality. Tyche was also cited for poor documentation practices, inadequate equipment cleaning procedures that posed risks of cross-contamination, and failing to properly test incoming raw materials for identity verification. The agency also placed Tyche’s products on Import Alert 66-40, barring them from U.S. importation.
ProRx, LLC, Warning Letter, 04 March 2025
ProRx, LLC received a warning letter on 04 March 2025. The warning letter was a result of an inspection conducted at the company’s Exton, Pennsylvania facility from 15 July 2024 to 02 August 2024. During the inspection, FDA investigators noted that drug products produced by ProRx, LLC failed to meet the conditions of section 503B. For example:
- The facility compounded drug products using a bulk drug substance from a specified manufacturer that is not a registered establishment under section 510 of the FD&C Act.
- The facility’s drug products, including Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml, and Vancomycin 25mg/ml 10ml, did not include all required labeling information.
- The facility did not submit adverse event reports to the FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of the Federal Regulations (or any successive regulations).
FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the company’s drug products to be adulterated under section 501(a)(2)(A) of the FD&C Act. The investigators had several findings that included failing to establish:
- Appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
- An adequate system for monitoring environmental conditions in the aseptic processing area.
- An adequate Quality Unit and the responsibilities and procedures applicable to the Quality Control unit were not in writing and fully followed.
- An adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
The World Health Organization (WHO)
WHO Publishes Guideline on Continuous Manufacturing, 05 February 2025
The recently published draft of the WHO guideline WHO Points to consider in continuous manufacturing of pharmaceutical products is intended to provide a global framework for the implementation of continuous manufacturing processes in the pharmaceutical industry. It is aimed at manufacturers as well as regulatory authorities. The guideline addresses the following topics:
- Fundamentals of continuous production
- Regulatory requirements
- Quality Risk Management (QRM)
- Technical aspects: automation, digitalization, equipment, and infrastructure
- Training and skill building
Medical Product Alert No1/2025: Falsified (Contaminated) Oxycontin 80 mg, 12 March 2025
This WHO Medical Product Alert refers to one batch of falsified OXYCONTIN 80mg (oxycodone hydrochloride). The falsified product was detected in the unregulated market in Switzerland and was reported to WHO in February 2025 by the genuine manufacturer MUNDIPHARMA. The falsified product imitates genuine Oxycontin 80mg authorized in Poland. Laboratory testing of samples of the falsified product was conducted by the Drug Information Centre of the city of Zurich (DIZ), Switzerland. DIZ’s drug checking service determined that the tablets did not contain oxycodone, but a synthetic opioid likely to be a nitazene compound. Nitazene derivatives (e.g., metonitazene, isotonitazene, fluonitazene) are potent synthetic opioids, primarily used in research due to their high addiction potential and severe side effects. These substances can be hundreds of times stronger than oxycodone, posing a high overdose risk. Limited information is available on their risks, toxicity, side effects, and long-term consequences.
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