FDA 483 - LGM Pharma LLC - December 04, 2018

LGM Pharma, LLC in Erlanger, Kentucky, an API relabeler, was cited for significant quality system deficiencies during an FDA inspection. Observations included improper relabeling of API products without testing, inadequate supplier qualification, and a dysfunctional quality unit. The firm also failed in complaint investigation, deviation management, recall procedures, product traceability, GMP training, storage conditions, and computer system validation, indicating a severe lack of control over critical pharmaceutical operations.