FDA 483 - Glenmark Pharmaceuticals Limited - May 20, 2022

Glenmark Pharmaceuticals Limited, a drug manufacturer in Colvale, Goa, India, was cited for significant deficiencies across its quality system. The inspection revealed widespread issues with inadequate investigations into product failures and discrepancies, insufficient process validation, and deficient laboratory controls for chromatographic analysis. Additionally, the firm's batch records lacked complete information, and manufacturing equipment was not appropriately designed.