The federal agents acted after the US attorney Catherine Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.
The seizure followed an inspection of several of the company’s plants where the FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.
The inspection also exposed the company’s manufacturing and distribution of other unapproved drug products. The seized drugs have been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.
FDA took the action as part of its effort to ensure that all drugs marketed in the US have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said: “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”