# FDA 483 - Glenmark Pharmaceuticals Limited - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/glenmark-pharmaceuticals-limited/61572250-35a3-4c58-8beb-ef4ed0be77a2

> FDA 483 for Glenmark Pharmaceuticals Limited on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Glenmark Pharmaceuticals Limited in Colvale Bardez, Goa, revealed significant deficiencies in their non-sterile drug manufacturing operations. The firm was cited for inadequate equipment cleaning, repeated failures in out-of-specification (OOS) investigations, and a lack of proper quality control unit oversight. Further issues included scientifically unsound sampling plans and an unreliable stability program, indicating systemic problems with quality assurance and product release.

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## Related Officers

- [Sandra A. Hughes](https://www.globalkeysolutions.net/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1