FDA 483 - Glenmark Pharmaceuticals Limited - May 20, 2022

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality systems, manufacturing controls, and laboratory practices.

**Observation 1: Inadequate Investigations** Investigations into unexplained discrepancies and batch failures were not extended to other potentially affected batches or products. * **Leaking Tubes:** Numerous US market complaints for leaking tubes of Gel, Ointment, and Cream products manufactured on the same filling machine were not thoroughly investigated to identify a root cause or extended to all relevant products. Examples include Gel (INI103211322), Ointment (GOMC21115, GOMC18362, GOMC18371), and various other Gel and Cream products with similar leakage issues from 2019-2022. * **Tablet Failures:** Fourteen batches of [redacted] Tablets were rejected since May 2018 due to failures in [redacted], content uniformity, or stratified sampling. Ten OOT investigations occurred since January 2020. * Investigation INII02210272 for [redacted] Tablets identified high [redacted] setting causing powder segregation, but the corrective action (new limits) was not extended to other strengths. * Investigation OOSil0221029 for [redacted] Tablets [redacted] mg identified