FDA 483 - Glenmark Life Sciences Limited - July 05, 2019

An FDA inspection of Glenmark Life Sciences Limited in Ankleshwar, India, revealed significant deficiencies across multiple areas. Observations included inadequate personnel training and record-keeping, incomplete batch production and control records, and deficient control systems to prevent contamination. Furthermore, the firm failed to conduct comprehensive investigations into product impurities, indicating a lack of robust quality control.