FDA Enforcement and Recall Report Week of June 27

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.

FDA Recalls

This past week brought one of the more diverse series of recalls since in several weeks. It may be a sign the latest listeria recall is smaller in scope. It could also be the recall is just beginning to take shape. This past week a total of 18 notices posted, with 7 exclusively due to listeria and and another animal product recalled due to listeria and salmonella. Undeclared allergens followed with an equal number of 7 recall notices, largely due to peanuts. This is down from the 9 undeclared allergen postings from the previous week. 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 FDA compliance. Other recalls posted due to botulism in canned sardines, a risk of spoilage from Bolthouse Farms protein beverages, and salmonella in raw nuts. The risks of salmonella in raw nuts would also be an issue for FSMA under the Foreign Supplier Verification Program. Under this FSMA rule an importer would need to assess who controls the risk – which in the case of raw nuts sold to consumers will frequently be the foreign supplier. Understanding FSVP risk control will be crucial to FDA compliance.

 

FDA Warning Letters – GMPs

This week 11 Warning Letters posted. GMP lapses dominated with 8 of the 11 related to GMP or HACCP problems. Three of the Warning Letters addressed seafood or juice HACCP non-compliance. Juice and seafood HACCP is typically strictly followed making warning letters a sign of serious issues in the FDA compliance culture. The other five related to dietary supplement, medical device, and drug GMP issues. The other warning letters related to illegal drug residue in animal production, unapproved new drugs in a compounding pharmacy, and a clinical investigator’s non-compliance. Compounding pharmacies continue to make an apperance on the warning letter list since the new regulation. Oversight of this corner of the drug industry shows signs of increased focus and a need to monitor FDA compliance carefully.

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

Recalls Week of June 27

06/24/2016 Nature Valley Protein Chewy Bars and Simple Nut Bars Listeria monocytogenes General Mills
06/24/2016 GFS Cheesecakes Undeclared peanuts The Father’s Table
06/24/2016 Fresh Market Smoked TFM Supreme Nut Mix Bags Undeclared peanuts and soy Creative Snack Co.
06/24/2016 Snack Shoppe, Figi’s, Nature’s Mix Snack Mixes Due to Listeria monocytogenes contamination Figi’s Companies, Inc.
06/23/2016 Honey Maid Mondelēz Global LLC Undeclared peanut Mondelēz Global LLC
06/23/2016 Rad Cat Raw cat food Salmonella, Listeria monocytogenes Radagast Pet Food, Inc.
06/23/2016 Michael’s Naturopathic Programs Dietary Supplements Undeclared milk and soy Michael’s Naturopathic Programs
06/23/2016 Atlantic Spice Co. Sunflower Seeds Roasted Salted, Tropical Mix and Cranberry Health Mix snacks Listeria monocytogenes Atlantic Spice Company Inc.
06/22/2016 Bolthouse Farms Protein beverages Due to possible spoilage Bolthouse Farms
06/22/2016 Lance Oyster crackers Undeclared peanut Snyder’s – Lance, Inc.
06/21/2016 Whole Foods Market Raw Macadamias Salmonella Marin Foods Specialties, Inc.
06/21/2016 Al Rasheed Sardine Potential for botulism Greenland Trading Corporation
06/21/2016 C & W Early Harvest Petite Peas and Petite Peas Listeria monocytogenes Pinnacle Foods Inc.
06/21/2016 Dutch Treat Foods, Inc. Sweet Pea Pasta Salad Listeria monocytogenes Dutch Treat Foods, Inc.
06/21/2016 Spartan (for cheese cake) cheese cake Undeclared peanut SpartanNash
06/21/2016 Tippin’s Key Lime Pie Undeclared Peanut Tippin’s Gourmet Pies, LLC
06/20/2016 Bountiful Harvest, First Street, Great Value, more Frozen green peas and frozen mixed vegetables Listeria monocytogenes National Frozen Foods Corporation
06/19/2016 Integrated Food Service Ready-To-Eat Sandwiches Listeria monocytogenes Let’s Do Lunch, Inc., DBA Integrated Food Service

Warning Letters Week of June 27

May 27, 2016 MGM Cattle Co. LTD Dallas District Office Illegal Drug Residue Not Issued *
May 24, 2016 American Pure Whey Atlanta District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
June 16, 2016 Adriatic Seafood Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 14, 2016 Suisan Company, Ltd San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 13, 2016 S.R. Burzynski Manufacturing Facility Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 07, 2016 Millers of Wyckoff, Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
June 03, 2016 Qualgen Dallas District Office Unapproved New Drug/Compounding/Misbranding/Adulterated Not Issued *
June 02, 2016 TYRX Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 02, 2016 Valley Processing, Inc. Seattle District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 04, 2016 Berwickshire Electronic Manufacturing Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 14, 2016 Neuralight HD, LLC Center for Drug Evaluation and Research Sponsor/Investigator 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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