USFDA inspection at Hyderabad facility ends with Form 483 carrying 5 observations
COHANCE · price
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Cohance Lifesciences' Pashamylaram, Hyderabad manufacturing unit was inspected by the USFDA from July 27 to August 5, 2026. The inspection ended with a Form 483 carrying five observations. The company confirmed none relate to data integrity. Cohance is preparing a response with corrective and preventive actions (CAPAs) for submission within the required timeline. Management says the observations are addressable and it will work closely with the USFDA. No warning letter or import alert has been mentioned.
Form 483 with 5 observations is manageable in principle. Watch for any escalation to a warning letter or import alert, which would impact US business.