FDA 483 - RePharm LLC - July 03, 2019

Repharm LLC, a drug repacker and relabeler in Riverside, MO, was cited for significant quality control and GMP deficiencies during an FDA inspection. Observations included a lack of quality unit review and approval for batch records and SOPs, inadequate employee training, and a failure to investigate discrepancies and out-of-specification results. Additionally, the firm lacked scientific justification for expiration dates and failed to qualify equipment or document label inspections.