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

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/057fe8cd-6838-4327-af2d-357c2360ff67

> 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: Office of Biological Products Operations - Division I
- Summary: Glenmark Pharmaceuticals Limited, a drug manufacturer in Colvale, Goa, India, was cited for significant deficiencies across its quality system. The inspection revealed widespread issues with inadequate investigations into product failures and discrepancies, insufficient process validation, and deficient laboratory controls for chromatographic analysis. Additionally, the firm's batch records lacked complete information, and manufacturing equipment was not appropriately designed.

## 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/093337ff-63f2-4cf2-8f60-4218782af640)

## 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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1