FDA 483 - LGM Pharma LLC - April 08, 2022

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.