# FDA 483 - Glenmark Pharmaceuticals Limited - May 20, 2022

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/093337ff-63f2-4cf2-8f60-4218782af640

> FDA 483 for Glenmark Pharmaceuticals Limited on May 20, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2022-05-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - 2019-03-15](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/61572250-35a3-4c58-8beb-ef4ed0be77a2)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/1b6b5a08-12ee-4621-95d3-64968e415cc1)
- [483 - 2022-05-20](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/057fe8cd-6838-4327-af2d-357c2360ff67)

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/glenmark-pharmaceuticals-limited/8a329d32-4a7d-4062-8336-1a4c9455759e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c