Inspection of Unichem's Kolhapur facility by USFDA completed without observations

Drug firm Unichem Laboratories on Friday said inspection of its Kolhapur facility in Maharashtra by the US health regulator has been completed without any observations.

The company's newly commissioned active pharmaceutical ingredients (APls) facility in Kolhapur was inspected by the United States Food and Drug Administration (USFDA) from September 16 to 20, Unichem Laboratories said in a filing to BSE.

The inspection was a CGMP surveillance and pre-approval inspection and was successfully concluded without any FDA Form 483 issued, it added.

According to the USFDA, an FDA Form 483 is issued to a firm's management "at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts."