FDA Enforcement and Recall Report Week of May 16

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 saw only a small slow down in the barrage of FDA food recall notices related to the frozen food recall. This past week the recall notices continued as part of the frozen food recall connected to CRF Foods. A total of 28 recall notices posted – that is only a reduction of 7 notices compared to 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 64% of the recall notices (18 of the 28).

Undeclared allergens came in second with 4 of the 28 (a very small number compared to most weeks), four other pathogen recalls, a quality control recall due to over salting and a  hazard recall and one Sildenafil recall in a dietary supplement 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.

The frozen food recall will likely contninue to generate notices for the next week or two.

FDA Warning Letters

FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve no letters from  center for tobacco  for Family Smoking Prevention violations. This is unusual 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.

Similar to last week one warning letter was issued for claims leading to reclassification as a new drug. This week a warning letter designated several products as new drugs for express and implied disease claims.  Also interest to note a warning letter last week due to Sildenafil or analogs of Sidenafil. This connects with the recall from a separate company also related to Sildenafil. This is a common issue with dietary supplements, in particular male enhancement supplements.

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

FDA Recalls May 6 – May 13

FDA Warning Letters as of 5/16/16