# FDA 483 - Gland Pharma Limited - February 25, 2025

Source: https://www.keypedia.com/records/483/gland-pharma-limited/70a20d4e-7f81-4f39-a96a-62b49284ed6c

> FDA 483 for Gland Pharma Limited on February 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2025-02-25
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Gland Pharma Limited, a sterile drug substance manufacturer in Parwada, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate cleaning and disinfection processes in aseptic areas, failures in procedures to prevent microbiological contamination, and a lack of established production and process controls. These issues led to product quality failures and un-implemented corrective actions, raising concerns about the validated state of their manufacturing processes.

## Related Documents

- [483 - 2025-02-25](https://www.keypedia.com/records/483/gland-pharma-limited/fb07106b-c857-4b39-a785-8454b8e94d20)
- [483 - 2025-02-25](https://www.keypedia.com/records/483/gland-pharma-limited/cbe87036-e58e-4399-96df-f7f954f37d22)

## Related Officers

- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)

Company: https://www.keypedia.com/companies/gland-pharma-limited/2bdef9e1-be40-4167-95c8-f08cba22365c

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