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

Source: https://www.keypedia.com/records/483/piramal-pharma-limited/ac3d292a-1498-4b43-8212-a948c2837186

> 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: Foreign - CDER (Non-Bioresearch Monitoring)
- Summary: An FDA inspection of Piramal Pharma Limited in Sangareddy District, Telangana, India, from February 9-13, 2025, revealed significant deficiencies in their quality systems. Observations included a lack of written procedures for quality control unit responsibilities, inadequate investigation records for out-of-specification results, and missing written procedures for equipment cleaning and maintenance. Additionally, production and process control procedures were not properly documented at the time of performance, indicating a need for improved adherence to good manufacturing practices.

## 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/foreign-cder-non-bioresearch-monitoring/279f5818-f62e-40c9-951c-cfbc7f929fa1