USFDA inspection of Unichem Lab’s Roha facility completed with no observation

Drug firm Unichem Laboratories on Monday said the US health regulator has completed inspection of its Roha facility in Maharashtra without any observation. The United States Food and Drug Administration (USFDA) conducted inspection at the company’s active pharmaceutical ingredients (APls) manufacturing unit at Roha from February 17 to 21, 2020, Unichem Laboratories said in a BSE filing.

“The inspection was a routine cGMP surveillance and successfully concluded without any FDA form 483 issued,” it added.

As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.

Shares of Unichem Laboratories closed at Rs 148.20 per scrip on the BSE, up 8.45 per cent from its previous close.