# FDA 483 - Piramal Pharma Solutions Inc. - January 10, 2023

Source: https://www.globalkeysolutions.net/records/483/piramal-pharma-solutions-inc/6a58d3a0-7021-4880-9eea-6344d3b09e99

> FDA 483 for Piramal Pharma Solutions Inc. on January 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piramal Pharma Solutions Inc.
- Inspection Date: 2023-01-10
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Piramal Pharma Solutions Inc in Lexington, KY, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adhere to quality control unit procedures, did not record or justify deviations from test methods, and maintained inadequate equipment and laboratory records. These issues indicate systemic problems with quality management and data integrity.

## Related Documents

- [483 - 2025-12-10](https://www.globalkeysolutions.net/records/483/piramal-pharma-solutions-inc/dd66836a-471c-4b3b-a600-f2c3a1dd3a0f)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.globalkeysolutions.net/companies/piramal-pharma-solutions-inc/6f76e56a-f4c5-4adb-9b46-093b7f8cd596

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22