# FDA 483 - Piramal Pharma Limited - February 13, 2025

Source: https://www.keypedia.com/records/483/piramal-pharma-limited/887f7fe0-6974-4e66-b630-913ccc8b4808

> FDA 483 for Piramal Pharma Limited on February 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piramal Pharma Limited
- Inspection Date: 2025-02-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Piramal Pharma Limited in Sangareddy District, India, was cited for significant deficiencies in its quality control, production, and documentation practices during an FDA inspection. Observations included a lack of written procedures for alarm review and equipment maintenance, inadequate OOS investigations, and insufficient documentation of critical process parameters and yields in batch records. These issues indicate a systemic breakdown in ensuring product quality and compliance.

## Related Documents

- [483 - 2025-02-13](https://www.keypedia.com/records/483/piramal-pharma-limited/ac3d292a-1498-4b43-8212-a948c2837186)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/piramal-pharma-limited/426a2612-5a5c-4bc9-9073-420430b16072

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