FDA recently warned a dietary supplement company for illegally producing drugs because its products contained undeclared active pharmaceutical ingredients. In an unusual case, the company was also cited for refusing to grant the FDA inspector access to an inventory of sampled products, as required by the inspection notice. FDA issued this warning pursuant to new authorities under the Food and Drug Administration Safety and Innovation Act, or FDASIA, which, as described in guidance, allows the agency to deem a product adulterated if it was manufactured or packaged in a facility that delays an inspection, limits access to certain areas or records, or refuses entry altogether.

In addition, FDA cited two dairy farms for illegal drug residue found in cows sold for slaughter. It also sent warning letters to two seafood processing facilities for hazard analysis and critical control points ("HACCP") violations, including failing to list maximum and minimum critical points, keep adequate compliance records, and provide corrective actions in the HACCP plan.

View the FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.