Regulatory Surveillance Summary | December, 2019

By Laurel Hacche, SQA Associate

SQA Regulatory Surveillance Summary for Q3-Q4, 2019

United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs)

Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019

This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance document is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. Medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used during minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems. These devices often have hydrophilic and/or hydrophobic lubricious coatings (e.g., polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone) to reduce friction between devices, and between device(s) and blood vessels. It is commonly believed that these coatings may offer physicians greater maneuverability and may result in less trauma to blood vessels for patients.

Drug Guidance: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product – Compliance Policy, September 2019

This guidance is intended for wholesale distributors who must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(c)(4)(D)). This guidance addresses the readiness of wholesale distributors to comply with the provisions in section 582 of the FD&C Act related to the verification of saleable returned drug products. The requirement under section 582(c)(4)(D) for wholesale distributors to verify saleable returned drug products prior to redistribution goes into effect on November 27, 2019. This guidance announces the Food and Drug Administration’s (FDA or the Agency) compliance policy regarding enforcement of the verification of saleable returned product requirement under section 582(c)(4)(D) of the FD&C Act. FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the FD&C Act. This represents a one-year delay in enforcement of the requirement for wholesale distributors to verify a product identifier prior to further distributing that returned product.

United States Food and Drug Administration (US FDA) Recalls (Devices, Cosmetics, and Drugs)

Device Recall: Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention, July 2019

The Edwards SAPIEN 3 Ultra Delivery System is used to deliver and deploy the Edwards SAPIEN transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. This System is indicated for use in patients with severe, symptomatic, aortic valve stenosis (narrowing of the heart’s aortic valve that restricts blood flow to the aorta, the body’s main artery). Edwards Lifesciences has received reports of burst balloons during implantation procedures, which have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or surgical intervention. The following warning will also be added to the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Instructions for Use (IFU): “Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention.”

Cosmetic Recall: Claire’s Stores, Inc. Announced a Voluntary Recall of Three Cosmetic Products, March 2019

Out of an abundance of caution, Claire’s Stores, Inc. announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder, and Claire’s Contour Palette. Claire’s initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

Drug Recall: Aurobindo Pharma USA, Inc. Voluntary Recall of Ranitidine Tablets, November 2019

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150 mg to the retail level and 37 lots of Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in the finished product. The impurity detected is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

United States Food and Drug Administration (US FDA) Warning Letters (Devices, Cosmetics, and Drugs)

Device Warning Letter: Denterprise International, Inc., October 2019

FDA issued a warning letter to Denterprise International, Inc. citing violations including failure to properly report complaints that patients were accidentally exposed to additional radiation. The agency asked the company to explain whether the exposures were due to device malfunction. In its warning letter to Denterprise, FDA said the company’s complaint records lacked required information including whether individuals were exposed to additional radiation due to a device malfunction. FDA said complaint records reviewed during its inspection revealed device malfunctions involving additional radiation exposures that were not reported to FDA. FDA focused on three specific complaints in the company’s records. It found Denterprise did not report on an allegation that its QuickRay HD dental X-ray sensor device stopped without saving data, resulting in 16 additional radiation exposures affecting 12 patients. A second complaint of “grainy images” resulted in four additional exposures, and a third complaint of “white images” resulted in two additional exposures.

Cosmetic Warning Letter: Color Art, Inc., September 2019

FDA sent out a warning letter to Color Art, Inc. regarding adulterated and misbranded cosmetics due to microbial contamination in tattoo inks that are on the market. The Warning Letter states: “The tattoo inks that you manufacture are adulterated…in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Specifically, during the inspection of your Miami Gardens facility, our investigator documented, based on your statements during the inspection, that the gallon containers you use to hold your firm’s basic color inks which are used to manufacture your finished tattoo inks have not been cleaned in almost years. New lots of ink are poured in the tanks without proper cleaning. Lack of cleaning of the gallon container can lead to growth of microorganisms within the container. Contaminated product which remains in the container could potentially contaminate subsequent batches of the base color, leading to contamination of the finished tattoo ink products.”

Drug Warning Letter: McKesson Corp., February 2019

The U.S. Food and Drug Administration has sent a warning letter to drug distributing giant McKesson Corp. for allegedly shipping pharmacies opioid products with pills missing or non-opioid replacements. The agency documented several alleged incidents when the company shipped tampered opioid products, stemming from what it found during inspections of McKesson’s corporate headquarters and a distribution center. In its warning letter, the agency cites the company for allegedly failing to sufficiently respond, quarantine, and investigate shipments of oxycodone hydrochloride sent to three Rite Aid pharmacies in 2016 after McKesson had been notified about the tampering issues.