FDA 483 - Glenmark Pharmaceuticals Limited - June 22, 2022

Glenmark Pharmaceuticals Limited, a non-sterile finished drug manufacturer in Baddi, India, was cited for six observations during an FDA inspection. Key issues include failures to thoroughly review discrepancies and batch failures, inadequate equipment cleaning and maintenance, unsubmitted Field Alert Reports for failing products, and insufficient written procedures for process controls. These findings indicate significant concerns regarding quality control, process validation, and data integrity.