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.
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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