FDA 483 - LGM Pharma LLC - June 28, 2024

LGM Pharma LLC, a distributor in Erlanger, KY, was cited for significant deficiencies in its quality system related to supplier management. The inspection revealed inadequate qualification of API suppliers, including a failure to perform onsite audits and premature approval of manufacturers. Additionally, the firm lacked written procedures for external audits and failed to qualify third-party auditors.