# FDA 483 - Glenmark Pharmaceuticals Limited - September 27, 2019

Source: https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/1b6b5a08-12ee-4621-95d3-64968e415cc1

> FDA 483 for Glenmark Pharmaceuticals Limited on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Glenmark Pharmaceuticals Limited, a non-sterile drug manufacturer in Colvale Bardez, Goa, India, revealed two significant observations. The firm failed to adequately correct a previous observation regarding cleaning documentation for equipment and utensils. Additionally, production and process control procedures were not followed, leading to unsealed drums of in-process material.

## Related Documents

- [483 - 2019-03-15](https://www.keypedia.com/records/483/glenmark-pharmaceuticals-limited/61572250-35a3-4c58-8beb-ef4ed0be77a2)
- [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

- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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