FDA Enforcement and Recall Report Week of June 23

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

Signs that listeria related recalls may be trending downward emerge this week.  A total of 20 new recall postings were posted.From this only 9 were related to Listeria. This is the first week in several where Listeria does not constitute a majority of the recalls. This week an equal amount of undeclared allergens – 9 in total – were also posted. As discussed before undeclared allergens points to lapses in the GMP program. Under FSMA the GMP program along with the hazard analysis under HARPC is expected to mitigate the number of undeclared allergen recalls. This rule takes effect in the autumn. Facilities need to update GMP procedures to ensure compliance.

The other two recalls related to salmonella and a potential for premature product spoilage. The premature spoilage announced by Muscle Milk is related to a packaging defect, which could also point to GMP lapses.

FDA Warning Letters – GMPs

This week 11 Warning Letters posted. GMP lapses dominated with 7 of the 11 related to GMP problems. The most interesting this past week was the Whole Foods Warning Letter. It is interesting on two grounds. First it highlights that even large companies with adequate staff and resources can fall out of compliance. Second the Whole Foods Warning Letter is the result of a facility inspection and Form 483. The mishandled response lead to the Warning Letter. A Form 483 response can often be seen as trivial, but it is vital to avoid complicating a manageable situation.

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

Recalls Week of June 23

Warning Letters Week of June 23