# FDA 483 - Glenmark Pharmaceuticals Limited - April 20, 2019

Source: https://www.globalkeysolutions.net/records/483/glenmark-pharmaceuticals-limited/b7ff58c7-f479-4ebb-a95a-ce9b1c103a62

> FDA 483 for Glenmark Pharmaceuticals Limited on April 20, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Limited
- Inspection Date: 2019-04-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Glenmark Pharmaceuticals Limited in Baddi, India, received an FDA Form 483 citing significant deficiencies across multiple areas of its finished drug manufacturing operations. The inspection revealed failures in thorough investigations of product discrepancies, inadequate stability testing, and a lack of robust process validation and equipment cleaning procedures. Additionally, issues with employee training, field alert reporting, laboratory controls, and document management were identified, indicating systemic quality control concerns.

## Related Documents

- [483 - 2017-11-11](https://www.globalkeysolutions.net/records/483/glenmark-pharmaceuticals-limited/da1521e9-2291-4a93-9ea2-3fdff9b7facf)
- [WARNING_LETTER - 2019-04-20](https://www.globalkeysolutions.net/records/warning_letter/glenmark-pharmaceuticals-limited/564e19c0-f3be-4691-97d4-7b89ca5fceb2)
- [483 - 2022-06-22](https://www.globalkeysolutions.net/records/483/glenmark-pharmaceuticals-limited/bbfcf848-0ee0-45ac-a30f-6b77a402de44)
- [WARNING_LETTER - 2022-05-20](https://www.globalkeysolutions.net/records/warning_letter/glenmark-pharmaceuticals-limited/0ac1907c-5a77-4f23-8229-957f8b7079ca)

## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)
- [Doug Cadre](https://www.globalkeysolutions.net/people/doug-cadre/b555b16a-58e5-435c-9a46-352863b57a8c)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/glenmark-pharmaceuticals-limited/66c964bb-f670-493b-ab86-aa8507e68a5d

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