# FDA 483 - Glenmark Pharmaceuticals Limited - June 22, 2026

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/e98bef36-5600-4902-bbe5-6b857ceb88c1

> FDA 483 for Glenmark Pharmaceuticals Limited on June 22, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2026-06-22
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Glenmark Pharmaceuticals Limited, a drug manufacturer in Colvale, India, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with inadequate cleaning procedures, lack of validated disinfectant contact times, and insufficient controls over computer systems and data integrity. Additionally, the firm failed to properly test high-risk components, maintain adequate environmental controls, and conduct comprehensive annual product reviews and risk assessments.

## 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)
- [483 - 2022-05-20](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/093337ff-63f2-4cf2-8f60-4218782af640)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3