FDA Enforcement and Recall Report Week of May 31

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 – Allergen Recalls

Recall postings can be slow following a holiday. This week is no exception with the recent Memorial Day holiday. Only three new recall postings. All three postings related to allergen recalls. This is a small number and likely posting due to the urgency of pulling allergen products.

As the CRF recall continues to cool – this week will provide evidence of how many recalls remain – expect to see allergen recalls swing back to the top. Undeclared allergens are traditionally the top reason for recalls. That will change as FSMA goes into effect – the FDA is requiring all allergens be declared or properly controlled under the HARPC rule.

FDA Warning Letters

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

A full nine (5) letters were issued for Good Manufacturing Practice (GMP or cGMP) or HACCP 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.

A rare interstate conveyance sanitation warning letter was issued to Horizon Air. This is an uncommon warning letter involves the ability for air cabin crews to properly wash their hands on the aircraft during beverage and food service. It can be difficult to predict where the FDA will inspect, which is all the more reason to prepare and plan in advance!

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

FDA Recalls May 24 – May 31

05/28/2016 365 by Whole Foods Market Kimchi, Fried Rice, Guacamole Undeclared fish, shellfish or tree nuts (pine nuts) Whole Foods Market
05/27/2016 Sweet Earth Burrito Undeclared milk Sweet Earth
05/27/2016 Domaine de Provence Tart shells Undeclared egg and coconut Sid Wainer &

FDA Warning Letters as of 5/31/16

November 06, 2015 Jh Seafood Supply Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 25, 2016 Hari Cards & Convenience, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 20, 2016 Corden Pharma Latina S.p.A. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
May 19, 2016 Megafine Pharma Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
May 19, 2016 Seedling Enterprise, LLC Detroit District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 18, 2016 Bedford Pharmacy New England District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
May 13, 2016 Horizon Air Industries Inc. Seattle District Office Interstate Conveyance Sanitation Regulations Not Issued *
March 10, 2016 Complete Pharmacy and Medical Solutions LLC Florida District Office CGMP/Compounded Drugs/Misbranding 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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