FDA Enforcement and Recall Report Week of June 23

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

FDA Recalls

Signs that listeria related recalls may be trending downward emerge this week.  A total of 20 new recall postings were posted.From this only 9 were related to Listeria. This is the first week in several where Listeria does not constitute a majority of the recalls. This week an equal amount of undeclared allergens – 9 in total – were also posted. As discussed before undeclared allergens points to lapses in the GMP program. Under FSMA the GMP program along with the hazard analysis under HARPC is expected to mitigate the number of undeclared allergen recalls. This rule takes effect in the autumn. Facilities need to update GMP procedures to ensure compliance.

The other two recalls related to salmonella and a potential for premature product spoilage. The premature spoilage announced by Muscle Milk is related to a packaging defect, which could also point to GMP lapses.

FDA Warning Letters – GMPs

This week 11 Warning Letters posted. GMP lapses dominated with 7 of the 11 related to GMP problems. The most interesting this past week was the Whole Foods Warning Letter. It is interesting on two grounds. First it highlights that even large companies with adequate staff and resources can fall out of compliance. Second the Whole Foods Warning Letter is the result of a facility inspection and Form 483. The mishandled response lead to the Warning Letter. A Form 483 response can often be seen as trivial, but it is vital to avoid complicating a manageable situation.

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

Recalls Week of June 23

06/18/2016 Whole Foods Pesto Pasta Salad with Arugula Listeria monocytogenes Green Cuisine
06/17/2016 Muscle Milk Multiple varieties of Muscle Milk Potential for premature product spoilage HP Hood LLC
06/17/2016 Tippin’s Key Lime Pie Undeclared Peanut Tippin’s Gourmet Pies, LLC
06/17/2016 GMJ Natural Products Jugo Moringa Plus Antioxidant, dietary supplement Undeclared Milk and Soy Lecithin GMJ Natural Products Inc.
06/17/2016 Earnest Eats Dark Chocolate Almond Chewy Granola Bars Listeria monocytogenes Earnest Eats
06/17/2016 Gardner Pie Company Cheesecakes and Key Lime Pies Undeclared Peanut Gardner Pie Company
06/17/2016 Bountiful Harvest, First Street, Great Value, more Frozen green peas and frozen mixed vegetables Listeria monocytogenes National Frozen Foods Corporation
06/16/2016 Kashi Go Lean and Bear Naked Snack Bars and Granola Listeria monocytogenes Kashi Company
06/16/2016 Zupan’s Markets Macaroni Salad with Cheddar Cheese Listeria monocytogenes Zupan’s Markets
06/16/2016 Globespun 4 Varieties of Flavored Wraps Listeria monocytogenes Essential Foods Inc.
06/16/2016 Crescent Raw Pistachios Salmonella contamination Crescent Specialty Foods Inc.
06/16/2016 HelloFresh Frozen Peas Listeria monocytogenes HelloFresh
06/16/2016 Armour Snackmakers Keebler Animal Crackers Undeclared Peanut Residue Armour-Eckrich Meats LLC
06/15/2016 None Chocolate flavored cookies Undeclared Milk Sinosharp Import & Export Co.
06/15/2016 Doritos Spicy Sweet Chili Doritos tortilla chips Undeclared Milk Frito-Lay
06/14/2016 Tosi Cappuccino Crunch SuperBites Undeclared Milk & Soy Simple Health LLC
06/14/2016 COMBOS Baked Pretzel & Cracker Snacks Undeclared Peanut MARS Chocolate North America
06/13/2016 Mother’s, Keebler, Kellogg’s Special K brownies, Murray and Famous Amos Snacks and Cookies Undeclared Peanut Kellogg Company
06/13/2016 Honey Bunchies Gourmet Honey Bars Listeria monocytogenes Honey Bunchie, LLC
06/13/2016 Creative Snacks Co. Sunflower Seeds and Trail Mixes Listeria monocytogenes Creative Snacks Co.

 

Warning Letters Week of June 23

May 23, 2016 PCP LV LLC dba Pinnacle Compounding Pharmacy San Francisco District Office CGMP/Compounded Drugs/Adulterated Not Issued *
May 19, 2016 Douce France Bakery San Francisco District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 09, 2016 smokersdiscounts.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 09, 2016 The Compounding Pharmacy of America New Orleans District Office CGMP/Compounded Drugs/Misbranding Not Issued *
June 08, 2016 Whole Foods Market North Atlantic Kitchen New England District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 07, 2016 AMJ Distribution Company Minneapolis District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
June 06, 2016 People’s Custom Rx and Clinical Care, LLC New Orleans District Office CGMP/Compounded Drugs/Misbranding Not Issued *
June 03, 2016 Eric Cherne Kansas City District Office Illegal Drug Residue Not Issued *
June 03, 2016 Focus Laboratories, Inc. Dallas District Office Medical Foods and New Drug Labeling/Internet Claims/Misbranded Not Issued *
June 02, 2016 Austin Biotechnology Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 02, 2016 Thomas Veterinary Services PLC Cincinnati District Office New Animal Drug/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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