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

Source: https://www.keypedia.com/records/483/gland-pharma-limited/fb07106b-c857-4b39-a785-8454b8e94d20

> 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 Inspections and Investigations
- Summary: An FDA inspection of Gland Pharma Limited in Parawada, India, a sterile drug substance manufacturer, revealed significant deficiencies across three observations. The firm was cited for inadequate cleaning and disinfection practices in aseptic processing areas, failures in procedures to prevent microbial contamination, and a lack of adequate written procedures for production and process controls. These issues indicate a compromised state of control over critical manufacturing processes for sterile drug substances.

## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8