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

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-ltd/0ced202b-767c-4244-95f5-a3ab861a6b47

> 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: Center for Drug Evaluation and Research
- Summary: This FDA Form 483, issued to Umesh Gupta, Senior VP & Site Head of Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India (FEI 3008565058), details observations from an inspection conducted from February 3-14, 2025. The facility is a drug manufacturer.

**Key Observations:**

1.  **Inadequate Equipment Cleaning and Contamination Control:**
    *   Failure to prevent cross-contamination of drug products manufactured on non-dedicated equipment, specifically with (b)(4) drug product residues.
    *   Approximately (b)(4) incidents since (b)(4) of detected (b)(4) carryover residue exceeding (b)(4) ppm after cleaning, impacting (b)(4) batches, including (b)(4) shipped to the US.
    *   Inadequate cleaning validation studies for (b)(4) Tablets, failing to consider the unique nature of (b)(4) drugs and contamination risk.
    *   No routine monitoring of (b)(4) residue before (b)(4), leading to (b)(4) impacted batches shipped to the US.
    *   Lack of decontamination agents for equipment used in (b)(4) drug products before manufacturing (b)(4) drug products.
    *   Personnel entry/exit procedures allow operators to work in both (b)(6) and (

## 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/1cc89a1d-cf2b-4d72-9e95-834b6d737023)
- [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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c