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

FDA Warning Letters as of 5/09/16