FDA Exempted Banned Generic Factories

Investigative testing and internal inspection records show the FDA has been allowing generic drugs or ingredients made in factories previously banned for unsafe practices to continue entering the U.S. supply via special exemptions; labels and public inspection reports are redacted so patients and doctors often cannot link a product to a problematic plant. ProPublica’s lab tests found underdosing in generic tacrolimus and inspectors reported contamination, destroyed test records, mold and fouled sterile equipment. — This exposes a transparency and safety gap in the U.S. drug supply that can directly harm patients and should drive debates over FDA disclosure, import policy, and supply‑chain resilience.