FDA 483 - MEDGEL PRIVATE LIMITED - February 21, 2025

MEDGEL PRIVATE LIMITED received a Form 483 citing significant deficiencies in equipment maintenance, cleaning validation, and process controls. Inspectors found contaminated manufacturing equipment, inadequate cleaning procedures, and a lack of proper process validation and hold time studies for drug products. The firm also failed to adequately monitor critical environmental conditions and investigate discrepancies, leading to the release of potentially compromised drug products.