# FDA 483 - Piramal Pharma Limited - February 17, 2025

Source: https://www.keypedia.com/records/483/piramal-pharma-limited/3ec9f2dc-312e-45fb-83ef-0a88f8c15929

> FDA 483 for Piramal Pharma Limited on February 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piramal Pharma Limited
- Inspection Date: 2025-02-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Piramal Pharma Limited, an API manufacturer in Navi Mumbai, India, received an FDA Form 483 citing multiple significant deficiencies during an inspection. Observations included inadequate quality control unit procedures, insufficient investigation follow-up for API deviations and customer complaints, unvalidated cleaning procedures for shared equipment, incomplete master production records, and improper handling and storage of key starting materials and APIs leading to contamination. These issues indicate a lack of robust quality systems and controls over critical manufacturing processes.

## Related Documents

- [483 - 2025-02-17](https://www.keypedia.com/records/483/piramal-pharma-limited/513ab9dc-e96b-4086-98d1-68ee7f1b1bd2)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/piramal-pharma-limited/c2aa1ac8-a474-4948-84c1-cd848c50558e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8