FDA Enforcement and Recall Report Week of July 4

 

FDA Recalls – General Mills and Raw Cookie Dough

Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters. This week is both late and light due to the Independence Day holiday, but the FDA’s response to the General Mills recall raised eyebrows.

Holiday recall postings are typically light. This week was no exception. Only four new recall notices posted but the General Mills recall still filled the news. Two related to undeclared allergens, one related to E. Coli and another to an unapproved new drug. Although only four in number the General Mills recall of raw flour made a number of waves. It lead the FDA to issue an absitence-only consumer update on eating raw cookie dough. This is an unusaul move – not every recall, even the large multi-state outbreaks, results in this type of advice. A dietary supplment was recalled for containing Sibutramine. As you may remember a weight loss supplement was recalled last month for the same reason.

 FDA Warning Letters – GMPs

This week 12 Warning Letters posted. Of the 12, 11 are linked to GMP lapses. The GMP Warning to Chongqing Lummy is surprising because it alleges intentional  data manipulation including setting computer clocks back to make tests appear as if they had been conducted earlier. This type of conducts crops up from time to time. The FDA is in a particularly powerful position with this type of GMP warning letter because it can block all imports from the company. Popsalot received a warning letter for misbranding – it claimed gluten free when it wasn’t.

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

Recalls Week of July 4

 

07/01/2016 Cumberland Farms SEA SALT CARAMEL DELIGHTS Undeclared Peanut Allergen Cumberland Farms
07/01/2016 Dream Body Dietary Supplement Unapproved new drug Dream Body Weight Loss
07/01/2016 Gold Medal, Wondra, and Signature Kitchens Flour E. coli O121 General Mills
07/01/2016 Euro Custard Cake Undeclared Milk Eastland Food Corp

Warning Letters Week of July 4

June 29, 2016 Dreamland Trading Inc Minneapolis District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
June 23, 2016 Lavella Brothers Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 22, 2016 Coastal Meds, LLC. New Orleans District Office CGMP/Compounded Drugs/Misbranding Not Issued *
June 22, 2016 Guangzhou Haishi Biological Technology Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 21, 2016 Chongqing Lummy Pharmaceutical Co. Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Finished Pharmaceuticals/Adulterated Not Issued *
June 21, 2016 POPSALOT, LLC Los Angeles District Office Food Labeling/Misbranded Not Issued *
Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 27, 2016 Orthosoft, Inc. dba Zimmer CAS Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
June 29, 2016 Dreamland Trading Inc Minneapolis District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
June 23, 2016 Lavella Brothers Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 22, 2016 Guangzhou Haishi Biological Technology Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
February 13, 2015 Multimedical S.R.L. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 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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