FDA 483 - Richie Pharmacal Company, Inc. - December 12, 2024

Richie Pharmacal Company, Inc. in Glasgow, Kentucky, was cited for inadequate systems and processes to comply with the Drug Supply Chain Security Act (DSCSA) during an inspection from December 2-12, 2024. The firm's procedures for handling suspect and illegitimate products were found to be insufficient, lacking details on identification, investigation, and notification. Additionally, the company failed to implement adequate training programs and maintain signed, approved Standard Operating Procedures.