FDA 483 - LGM Pharma, LLC - April 14, 2022

LGM Pharma, LLC in Boca Raton, FL, was issued a Form 483 with two observations following an FDA inspection. The firm's quality system was found deficient, specifically regarding its vendor qualification procedures and the investigation of deviations. These issues indicate a lack of adequate control over the quality and status of active pharmaceutical ingredients (APIs) and their suppliers.