FDA 483 - Glenmark Pharmaceuticals Limited - April 20, 2019

Glenmark Pharmaceuticals Limited in Baddi, India, received an FDA Form 483 citing significant deficiencies across multiple areas of its finished drug manufacturing operations. The inspection revealed failures in thorough investigations of product discrepancies, inadequate stability testing, and a lack of robust process validation and equipment cleaning procedures. Additionally, issues with employee training, field alert reporting, laboratory controls, and document management were identified, indicating systemic quality control concerns.