FDA Enforcement and Recall Report Week of May 23

FDA Enforcement Report

**This week’s FDA enforcement report is tardy due to meetings on FDA’s White Oak campus (read a post on the visit here.)**

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

It seems this week evidence of a the CRF frozen food recall has begun to slow down. Only 16 recall notices posted – a significant reduction. Still a full 12 (75%) are related to Listeria. It may be another two or three weeks before recall notices return to normal. Undeclared allergens are making a come-back with three posted this week related to milk.

Increased concern for compounding pharmacy continues and this week there is a recall related to sterility.

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 nine (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. As can been this week GMP compliance can range from adulteration (safety) concerns to labeling (mibsranding) issues.

An intersting cross-over letter appeared as well for a new animal drug. The Warning Letter was issued for drugs given to calves. The USDA FSIS enjoys primary jurisdiction over animal production, but the FDA over animal feed and drugs. This cross-jurisdiction is highlighted in the Bridgewater Warning Letter.

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

FDA Recalls May 16 – May 24

05/24/2016 C. J. Dannemiller Co. Sunflower kernels Listeria monocytogenes C. J. Dannemiller Co.
05/24/2016 E.S. Foods Products containing sunflower kernels Listeria monocytogenes E.S. Foods
05/23/2016 Alpine Valley, Wegmans, Flave Fitness, Gonzo, more Products containing sunflower kernels Listeria monocytogenes First Source
05/22/2016 Hy-Vee Trail mix products Listeria monocytogenes Hy-Vee, Inc.
05/21/2016 Albertsons-Safeway, Bashas, more Oriental Salad with sesame ginger dressing Listeria monocytogenes Papa John’s Salad and Produce, Inc.
05/20/2016 Dakota Style Sunflower kernels Listeria monocytogenes Dakota Style Foods, Inc.
05/20/2016 Hickory Harvest, Big Y, Amish Farms, more Products containing sunflower kernels Listeria monocytogenes Hickory Harvest Foods
05/19/2016 Southern Grove, Naturally Select, more Sunflower seeds, kernels, trail mix products Listeria monocytogenes TreeHouse Foods, Inc.
05/19/2016 The Caramel Factory Candies, chocolates and baked goods Undeclared milk, eggs, peanuts, tree nuts, soy, and/or wheat The Caramel Factory, LLC
05/18/2016 Sunrich Naturals and Planters Sunflower kernel products Listeria monocytogenes SunOpta
05/18/2016 Amino Gold Supplements Undeclared milk Ultimate Nutrition
05/17/2016 Well Care Compounding Pharmacy Unexpired sterile compounded products Concern over lack of sterility assurance Well Care Compounding Pharmacy
05/17/2016 Birdy Coffee mix (Robusta) Undeclared milk Food Gusto Inc.
05/17/2016 Tai Pei, Trader Joe’s, Hy-Vee, more Frozen foods Listeria monocytogenes, CRF2016 Ajinomoto Windsor, Inc.
05/16/2016 Quaker Quinoa granola bars Listeria monocytogenes The Quaker Oats Company
05/16/2016 Stahlbush IQF Green Beans Listeria monocytogenes Stahlbush Island Farms, Inc.

FDA Warning Letters as of 5/25/16

May 18, 2016 khahan LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation Not Issued *
May 16, 2016 BBT Biotech Gmbh Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
May 16, 2016 David Bridgewater Cincinnati District Office New Animal Drug/Adulterated Not Issued *
May 16, 2016 N.A. Sales Company Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 16, 2016 Qiagen Sciences LLC Baltimore District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
May 13, 2016 Rocky Fork Formulas Inc Cincinnati District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
May 12, 2016 Hannibal Company Inc Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
May 12, 2016 Somnowell, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 12, 2016 Tai Heng Industry Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
May 05, 2016 Banner Pharmacy Services, LLC Los Angeles District Office CGMP/Compounded Drugs/Misbranding Not Issued *
May 05, 2016 Renovis Surgical Technologies, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 05, 2016 www.baracoatobacconist.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
February 05, 2016 Beauty & Health International Inc. Los Angeles District Office CGMP/Dietary Supplement/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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