FDA Enforcement and Recall Report Week of June 27

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.

FDA Recalls

This past week brought one of the more diverse series of recalls since in several weeks. It may be a sign the latest listeria recall is smaller in scope. It could also be the recall is just beginning to take shape. This past week a total of 18 notices posted, with 7 exclusively due to listeria and and another animal product recalled due to listeria and salmonella. Undeclared allergens followed with an equal number of 7 recall notices, largely due to peanuts. This is down from the 9 undeclared allergen postings from the previous week. 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 FDA compliance. Other recalls posted due to botulism in canned sardines, a risk of spoilage from Bolthouse Farms protein beverages, and salmonella in raw nuts. The risks of salmonella in raw nuts would also be an issue for FSMA under the Foreign Supplier Verification Program. Under this FSMA rule an importer would need to assess who controls the risk – which in the case of raw nuts sold to consumers will frequently be the foreign supplier. Understanding FSVP risk control will be crucial to FDA compliance.

FDA Warning Letters – GMPs

This week 11 Warning Letters posted. GMP lapses dominated with 8 of the 11 related to GMP or HACCP problems. Three of the Warning Letters addressed seafood or juice HACCP non-compliance. Juice and seafood HACCP is typically strictly followed making warning letters a sign of serious issues in the FDA compliance culture. The other five related to dietary supplement, medical device, and drug GMP issues. The other warning letters related to illegal drug residue in animal production, unapproved new drugs in a compounding pharmacy, and a clinical investigator’s non-compliance. Compounding pharmacies continue to make an apperance on the warning letter list since the new regulation. Oversight of this corner of the drug industry shows signs of increased focus and a need to monitor FDA compliance carefully.

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

Recalls Week of June 27

Warning Letters Week of June 27