483
LGM Pharma LLCLGM Pharma LLC – FDA 483, Apr 8, 2022
Record Details
LGM Pharma LLC, an Active Pharmaceutical Ingredient Distributor in Erlanger, KY, was cited for significant quality system deficiencies during an FDA inspection from March to April 2022. The firm failed to adequately investigate customer complaints and critical deviations, leading to potential distribution of compromised products. Additionally, the inspection revealed issues with recording quality activities and proper vendor qualification and oversight.
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ID · 91297ae6-fb36-4023-978e-58e9b301f0ea
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