FDA 483 - RePharm LLC

RePharm LLC, a drug repacker in Riverside, MO, received a Form 483 with two repeat observations during an FDA inspection. The firm failed to follow its written procedures, with many SOPs being generic, inaccurate, or not reflecting actual processes, and lacked validation protocols for critical equipment. Additionally, the inspection revealed that the firm did not adequately test drug product batches to determine appropriate expiration dates, showing deficiencies in stability testing, supplier qualification, and packaging material shelf-life management.