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

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

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Drug firm Unichem Laboratories announced that 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 (US FDA) from September 16 to 20, Unichem Laboratories said in a filing to BSE.

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

Shares of Unichem Laboratories were trading at Rs 194.60 per scrip on the BSE, up 2.96 per cent from its previous close.

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