# FDA 483 - Glenmark Pharmaceuticals Ltd - February 14, 2025

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-ltd/1cc89a1d-cf2b-4d72-9e95-834b6d737023

> FDA 483 for Glenmark Pharmaceuticals Ltd on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Ltd
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Glenmark Pharmaceuticals Ltd in Pithampur, India, revealed critical deficiencies in contamination control, facility segregation, and quality control. The firm failed to prevent cross-contamination due to inadequate cleaning and shared manufacturing areas for potent drugs. Additionally, there were significant issues with OOS investigations, analytical method validation, and timely completion of stability studies, indicating a systemic breakdown in quality assurance.

## Related Documents

- [483 - 2018-05-24](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-ltd/7fe7f73b-7011-4b70-82e3-f637a3a418ec)
- [483 - 2025-02-14](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-ltd/0ced202b-767c-4244-95f5-a3ab861a6b47)
- [WARNING_LETTER - 2025-02-14](https://www.keypedia.com/records/warning_letter/glenmark-pharmaceuticals-ltd/f05498db-6645-42ab-81ff-8a03eb201f2f)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/glenmark-pharmaceuticals-ltd/1e6c03ca-7a68-4506-9af3-70d64338538a

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8