# FDA 483 - Glenmark Pharmaceuticals Inc  USA - May 19, 2022

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-inc-usa/1b8b8fd4-51be-4814-beba-b692741bb894

> FDA 483 for Glenmark Pharmaceuticals Inc  USA on May 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Inc  USA
- Inspection Date: 2022-05-19
- Product Type: drugs
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: An FDA inspection of Glenmark Pharmaceuticals Inc USA revealed numerous deficiencies across its quality control, production, and laboratory operations. Key issues included a lack of authority for the quality control unit, inadequate investigation of discrepancies, and failures in maintaining sterile conditions and proper equipment. The findings indicate systemic problems in adhering to established procedures and ensuring drug product quality and safety.

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## Related Officers

- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)
- [Steven A Brattlie](https://www.keypedia.com/people/steven-a-brattlie/eb8f7b51-6206-4e7f-87df-2afd1a2e2515)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/glenmark-pharmaceuticals-inc-usa/83c18d68-8e9d-454a-a365-3fe29c7d3e31

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43