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

Richie Pharmacal Company, Inc., a wholesale distributor in Glasgow, Kentucky, was cited for inadequate systems and processes to comply with the Drug Supply Chain Security Act (DSCSA). The inspection revealed deficiencies in written procedures for identifying and investigating suspect products, as well as a lack of training programs and approved SOPs related to DSCSA verification requirements. These findings indicate significant non-compliance with critical drug supply chain security regulations.