USFDA29 Sept 2024, 05:24 am
Piramal Pharma Receives EIR from US FDA for Ahmedabad Manufacturing Facility
AI Summary
Piramal Pharma Ltd. has announced the receipt of an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its manufacturing facility located in Ahmedabad. This announcement comes after the US FDA inspection conducted on the facility on July 12, 2024, which resulted in zero Form 483 observations and a No Action Indicated (NAI) designation. The issuance of the EIR signifies the formal closure of the inspection.
Key Highlights
- Piramal Pharma receives EIR from US FDA for Ahmedabad manufacturing facility
- US FDA inspection on July 12, 2024, resulted in zero Form 483 observations
- Facility received a No Action Indicated (NAI) designation
- EIR marks the formal closure of the US FDA inspection
- Piramal Pharma's commitment to maintaining high-quality standards in manufacturing