Inspection Details
- Regulatory Authority: U.S. Food & Drug Administration (USFDA)
- Facility Inspected: Unit II formulation facility located at 297–298/2p, At. Valthera, Tal. Dholka, Dist. Ahmedabad–382225, Gujarat, India
- Inspection Conclusion Date: September 18, 2026
- Inspection Outcome: Successfully concluded
Inspection Findings
The USFDA issued one minor observation which is:
- Procedural in nature
- Not related to Good Manufacturing Practices (GMP)
Company Response
The Company will submit a comprehensive response to the observation within the stipulated timeline.
Business Impact Assessment
The Company states: "We do not expect this development to have any material impact on the current business operations or existing supplies from this facility."
Additional Information
- The disclosure was signed by Paritosh Trivedi, Company Secretary & Compliance Officer (ACS 63623)
- Company CIN: L24230GJ1984PLC007440