Enovachem Hit With FDA Warning Letter
The FDA issued a warning letter to Enovachem for serious deviations from current good manufacturing practices for its APIs, in a follow-up to a Sept. 25-27, 2018 inspection of the firm’s Torrence, California manufacturing facility.
The agency warned that the company “failed to obtain and retain documents with the identity of the original manufacturer and certificates of analysis (COA) from the original manufacturer” for an API the firm repackaged and distributed.
In addition, the agency noted a failure to include the names and addresses of the original API manufacturers on the COA the firm issued to customers. “Omitting information from the COA compromises supply chain accountability and traceability, and may put consumers at risk,” the agency said.