FDA Enforcement and Recall Report Week of April 26, 2016

FDA Enforcement and Recall Report Week of April 11 2016

Each week the FDA reports on its enforcement activities. To help capture and digest that information starting this week the FDA Atty blog will post FDA recalls and warning letters.

FDA Recalls

This past week the FDA posted 12 recall notices. That is two fewer recalls than the previous week. Those notices are posted below. The FDA recall notices continue to show undeclared allergens as the leading cause of recall. A total of 6, or 50% (same as last week) of the notices involve undeclared allergens. This will be an area of increased enforcement under FSMA’s allergen controls (see Food Safety Modernization Act; HARPC Rule).

An additional three recalls were due to microbial pathogens while one was due to a  physical hazard – potential glass. The final two likely stem from hazards – lack of sterility and a manufacturing defect.

 

FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve no center for tobacco retailer warning letters. This is unusual – typically retailer warning letters are the most commonly issued. Instead two firms were cited for gaps in their Good Manufacturing Practices (GMPs) program – one device and one drug. There was a second IRB letter – one was in last week’s report. One warning letter addressed pet food containing Salmonella and a second the conditions of a dairy farm.

 

Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.

 

FDA Recalls April 15-18

 

04/15/2016 Mary’s Home Made Vegetable Soup Clostridium botulinum Mary’s Home Canning
04/15/2016 Back to Nature Classic Creme Cookies Undeclared Milk Back to Nature Foods, LLC
04/24/2016 Brand Name Gold Emblem Abound Spiced Herbal Tea Salmonella CVS Pharmacy
04/23/2016 True Goodness, Wellsley Farms, Organic by Nature, Schwan’s Frozen vegetable products Listeria monocytogenes CRF Frozen Foods
04/22/2016 Chick-Fil-A Chick-Fil-A Chocolate Chunk Cookies Undeclared Peanuts CSM Bakery Solutions
04/21/2016 Life’s Qik Fix and Zuma Supreme Dietary Supplement Undeclared Milk and Soy Magzuma Nutrition
04/20/2016 Covidien Oridion Capnostream 20 and 20p patient monitors Battery manufacturing defect may increase the risk of thermal damage in the battery pack Medtronic
04/19/2016 Pharmakon Pharmaceuticals, Inc. Sterile compounded products Lack of sterility assurance Pharmakon Pharmaceuticals, Inc.
04/19/2016 StemVitae liquid multivitamin Undeclared milk and soy lecithin Nuvi Global Corporation
04/19/2016 Angel Wings Dietary Supplement Undeclared Milk and Soy Magzuma Nutrition
04/18/2016 Hosdo Hosdo Cake Undeclared Milk Midwest International Corp.
04/18/2016 Nice! Peach slices and mixed fruit Potential Glass Milky Way International Trading Corp.

 

FDA Warning Letters as of 4/26/16

March 17, 2016 Lystn, LLC dba Answers Pet Food Philadelphia District Office Interstate Commerce/Food/Adulterated Not Issued *
April 12, 2016 Vande Hey, Bruce Minneapolis District Office New Animal Drug/Adulterated Not Issued *
April 07, 2016 Oeyama-Moto Cancer Research Foundation IRB Center for Drug Evaluation and Research Institutional Review Board-IRB Not Issued *
April 06, 2016 Advanced Vision Science Inc Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 01, 2016 Sri Krishna Pharmaceuticals Ltd. – Unit II Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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