FDA Enforcement and Recall Report Week of May 9

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

Anyone subscribing to the FDA recall e-mail list received a barrage of FDA food recall notices. This past week the recall notices spiked dramatically. A total of 35 recall notices posted – that is 12 more than last week.

Typically FDA food recall notices involve undeclared allergens. This has been the case the past three weeks. A Listeria outbreak linked to CRF Foods impacting 358 products across 42 brands. The Listeria recalls constituted a full 60% of the recall notices (20 of the 35).

Undeclared allergens came in second with 11 of the 35, 2 other pathogen recalls, a physical hazard recall and one medical device recall rounded out the list.

A busy week demonstrating how interconnected the food supply chain can be. One key feature of FSMA is supplier verification and integration of the supply chain. A recall notice like CRF Foods highlights why supplier verification became a key component of FSMA.

 

FDA Warning Letters

FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve only two  center for tobacco  letters for Family Smoking Prevention violations. This is a small number compared to most weeks.

A full five (5) letters were issued for Good Manufacturing Practice (GMP or cGMP) issues. A week like this emphasizes how GMP issues are not confined to the FDA Form 483.

A final note on Warning Letters is a cosmetic warning letter. Cosmetic comapnies often feel immune or overlooked and therefore able to make more aggressive claims. This week a warning letter designated a cosmetic a new unapproved drug due to claims (hyper pigmentation, elasticity, and other structure/function claims) and other violations. Cosmetic companies above all others need to be careful in making claims.

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

FDA Recalls April 29-May 5

04/29/2016 7-Eleven 7-Eleven Fresh To Go Cookies Undeclared Peanuts Bakery Express of Central FL
04/29/2016 The Republic of Tea Organic Turmeric Ginger Green Tea Salmonella The Republic of Tea
04/29/2016 Cinnabon Cinnabon Stix Undeclared Peanut Allergen CSM Bakery Solutions
04/28/2016 Choice Products and New Life Undeclared Milk and Soy Lecithin Undeclared Milk and Soy Lecithin World’s Choice Products, Inc.
04/28/2016 7-Eleven 7-Eleven Fresh Baked Cookies Undeclared Peanuts 7-Eleven, Inc.
05/03/2016 Market District Sunflower Kernels Listeria monocytogenes Giant Eagle
05/03/2016 Beacon, Shuttle, Fluoro-Set, and others Catheters with Beacon Tip technology May exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation Cook Medical
05/03/2016 Blue Bell Rocky Road Ice Cream Undeclared Allergens Soy and Wheat Blue Bell Ice Cream
05/03/2016 Market District Sunflower Kernels Listeria monocytogenes Giant Eagle
05/03/2016 Southern Grove, Natures Harvest, Roundy and others Snacks containing sunflower kernels Listeria monocytogenes TreeHouse Foods, Inc.
05/02/2016 Vitalicious VITALICIOUS Apple Crumb VitaTops Undeclared Milk Allergen Vitalicious Acquisition LLC
05/02/2016 Giant Eagle Walnut Delight and Pecan Tassie cookies Undeclared Milk Allergen Giant Eagle
05/02/2016 Bybee’s,Columbia River Organics, Northwest Growers Select and others Frozen Organic and Traditional Fruits and Vegetables Listeria monocytogenes CRF Frozen Foods
04/30/2016 Safeway, ACME, and Jewel 8″ Single Layer Red Velvet Cake and 12″ Decorated Chocolate Chip Cookie Undeclared Peanut Allergen CSM Bakery Solutions
04/29/2016 Black Gold and 3rd Degree Marketed as a dietary supplement Undeclared Sibutramine and Sildenafil Making It A Lifestyl
05/05/2016 Publix Wheatberry Salad Containing Sunflower Kernels Listeria monocytogenes Publix Supermarkets Inc.
05/04/2016 Mountain Thins Mountain Thins “Trail Mix” Listeria monocytogenes Brown & Haley
05/04/2016 Kroger Sunflower Salad Toppers, Sunflower Kernels, and Cranberry Delight Trail Mix Listeria monocytogenes The Kroger Co.
05/04/2016 Market District Sunflower Kernels Listeria monocytogenes Giant Eagle
05/04/2016 Dakota’s Best Biggy’s and Planters Sunflower Kernels Listeria monocytogenes SunOpta
05/04/2016 Bybee’s,Columbia River Organics, Northwest Growers Select and others Frozen Organic and Traditional Fruits and Vegetables Listeria monocytogenes CRF Frozen Foods
05/04/2016 Southern Grove, Natures Harvest, Roundy and others Snacks containing sunflower kernels Listeria monocytogenes TreeHouse Foods, Inc
05/04/2016 Hickory Harvest, IM Good, Sheetz, and others Sunflower Kernels Listeria monocytogenes Hickory Harvest Foods
05/03/2016 Frontera Frontera Undeclared Soy Frontera Foods
05/03/2016 Market District Sunflower Kernels Listeria monocytogenes Giant Eagl
05/06/2016 Central Market Organic, HEB, Sweetfrost and Woodstock Vegetable Products Containing Organic Peas Listeria monocytogenes Twin City Foods, Inc
05/06/2016 Pulmuone Korean Noodles Undeclared Milk Pulmuone Foods USA
05/06/2016 Watts Brothers Farms, Trader Joe’s Frozen vegetable products Listeria monocytogenes ConAgra Foods
05/06/2016 Dorothy Lynch Home Style Dressing Dorothy Lynch Home Style Dressing Bacteria (lactobacillus) Tasty Toppings, Inc.
05/06/2016 Stahlbush IQF Green Beans Listeria monocytogenes Stahlbush Island Farms, Inc.
05/05/2016 Pita Pal Salads Listeria monocytogenes Pita Pal Foods, LP
05/05/2016 Watts Brothers Farms, Trader Joe’s Frozen vegetable products Listeria monocytogenes ConAgra Foods
05/05/2016 Creative Snacks Co., Heart Smart Mix, The Fresh Market, Plentiful Planet, and others Sunflower Seed Products bulk and packaged Listeria monocytogenes Creative Snacks Co.
05/05/2016 Millville Schulze and Burch Biscuit Co Listeria monocytogenes Schulze and Burch Biscuit Co.
05/05/2016 PharMEDium Sterile Preparations Compounded With Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Presence of glass particulate PharMEDium Services LLC

FDA Warning Letters as of 5/09/16

March 29, 2016 Oeyama-Moto-Medical Group Foundation, LLC Center for Drug Evaluation and Research Sponsor/Applicant/Monitor/Contract Research Organization Not Issued *
March 17, 2016 Grams Medical Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 29, 2016 Hookah1 Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 28, 2016 my-food-online Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 26, 2016 Home Style Foods, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 21, 2016 Hartley Medical Center Pharmacy, Incorporated Los Angeles District Office CGMP/Compounded Drugs/Misbranding Not Issued *
April 20, 2016 Crescent Health Center, Inc Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
April 15, 2016 Dutch Kettle (The) Atlanta District Office Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
April 15, 2016 Pacific Nutritional Inc Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
April 07, 2016 Apotheca Supply, Inc New Orleans District Office CGMP/Active Pharmaceutical Ingredient (API)/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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