FDA 483 - Glenmark Pharmaceuticals Limited - September 27, 2019

An FDA inspection of Glenmark Pharmaceuticals Limited, a non-sterile drug manufacturer in Colvale Bardez, Goa, India, revealed two significant observations. The firm failed to adequately correct a previous observation regarding cleaning documentation for equipment and utensils. Additionally, production and process control procedures were not followed, leading to unsealed drums of in-process material.