Institute of Good Manufacturing Practices India®

USFDA cGMP surveillance clearance of Unichem Labs API facility in Kolhapur


Unichem Laboratories has successfully completed the US health regulator audit of its new facility at Kolhapur, Maharashtra without any observations.

The cGMP surveillance of the USFDA inspection of the Active Pharmaceutical Ingredients (APls) facility located at Kolhapur was conducted from September 16, 2019, to September 20, 2019.

The inspection was successfully completed by the U. S Food and Drug Administration (USFDA) and no observations were issued to the facility.

As per the reports released, the inspection was a cGMP surveillance and pre-approval inspection and was successfully concluded without any FDA form 483 issued.

Form 483 is issued by the USFDA for the notification to a company’s management of any objectionable condition at its manufacturing facility. The form is issued on completing the inspection.

cGMP directs to the Current Good Manufacturing Practice regulations enforced by the USFDA. cGMPs is for providing systems that helps in ensuring proper design, monitoring, and control of manufacturing processes and facilities.