
USFDA21 Sept 2026, 11:38 am
Cohance Lifesciences Facility Inspected by USFDA; 5 Observations Issued
AI Summary
Cohance Lifesciences Ltd announced that its API manufacturing facility in Jaggaiahpet, Andhra Pradesh, was inspected by the United States Food and Drug Administration (USFDA) from September 14 to September 19, 2026. The inspection concluded with the issuance of a Form FDA 483, detailing five observations. The company has stated that it has initiated corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline. Cohance Lifesciences reaffirmed its commitment to quality and regulatory compliance.
Key Highlights
- USFDA inspected Cohance Lifesciences' API manufacturing facility.
- Inspection resulted in five observations on a Form FDA 483.
- Company is implementing corrective and preventive actions.
- Response to USFDA will be submitted within the timeline.
Price Impact
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