FDA Enforcement and Recall Report Week of June 6

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 picked up steam again this past week. After only three new recall postings preceding the Memorial Day holiday a full 23 recall postings this past week. It appears Listeria is continuing to drive the number of recalls – a full 16 of the 23 notices involved Listeria. This is likely still tied to the CRF recall.  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.

Also note the recall for insufficient pasteurization. As FSMA goes into effect it will not be enough to simply note a supplier pasteurizes a product, but to ensure that process is validated and adequately controlling the risk. This type of recall will soon have FSMA implications!

FDA Warning Letters

FDA Warning Letters post weekly but generally are issued earlier than posted. There were no new Warning Letters. This post will be amended when the latest Warning Letters are added.

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