FDA Enforcement and Recall Report Week of July 11

FDA Recalls

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. This week is both late and light due to the Independence Day holiday, but the FDA’s response to the General Mills recall raised eyebrows.

The post-Indepdence Day holiday lull continues on the recall and warning letter front. Recall posts are sparse with only three new listings. Two related to microbiological contamination and the other related to undeclared allergens. postings are typically light. Even from this small number of recalls there are lessons to be learned. Take the Krusteaz pancake mix recall. This recall is linked to the General Mills recall from last week. The pancake mix is recalled because “blueberry nuggets” were made using the General Mills flour. This link across industry highlights why supplier verification became a key cornerstone of FSMA. The food industry is linked in ways that are not always apparent. As FSMA takes effect it will be worth watching whether this type of recall increases or decreases. It would seem as supplier verification programs become more robust and pervasive at some point cross-linked recalls would reduce in number.

 FDA Warning Letters – GMPs

There were no new warning letters posted as of this morning. Please check back for updates.

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


Recalls Week of July 11

07/09/2016 Krusteaz Pancake Mix May be contaminated with E. coli O121 Continental Mills
07/09/2016 Kroger Deluxe S’mores Ice Cream Undeclared Peanut Allergen The Kroger Co.
07/06/2016 Evie’s Cheddar Potato Salad Listeria monocytogenes Hearn Kirkwood


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Marc Sanchez

Marc Sanchez

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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