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).
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