USFDA24 Jun 2025, 01:43 pm
Concord Biotech Receives USFDA EIR for Dholka API Facility - No Regulatory Action Required
AI Summary
Concord Biotech Limited has announced that it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection conducted at its API facility in Dholka. The USFDA inspection, which took place from April 28, 2025, to May 22, 2025, has been officially closed under 21 CFR 20.64(d)(3), indicating no regulatory action is required and the facility can continue its operations without restrictions.
Key Highlights
- Concord Biotech Limited has received an EIR from the USFDA for its API facility at Dholka.
- The USFDA inspection at the Dholka facility, conducted from April 28, 2025, to May 22, 2025, has been officially closed.
- No regulatory action is required for the Dholka facility, as per the USFDA EIR.
- The Dholka facility is permitted to continue its operations without any restrictions.
- This development indicates a positive regulatory relationship between Concord Biotech and the USFDA.