483
LGM Pharma LLCFDA 483 - LGM Pharma LLC - June 28, 2024
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Record Details
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.
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ID · 736cb79a-d2a0-4a5a-9ade-0d88191bfcb4