US FDA concludes inspection of Unichem Lab’s Roha facility
The United States Food and Drug Administration (US FDA) conducted inspection at the company's active pharmaceutical ingredients facility at Roha from September 9-12, 2019
Drug firm Unichem Laboratories said the US health regulator has concluded inspection of its Roha facility in Maharashra without making any observations. The United States Food and Drug Administration (US FDA) conducted inspection at the company’s active pharmaceutical ingredients facility at Roha from September 9-12, 2019. The inspection was a post-approval inspection and successfully concluded without any US FDA form 483 being issued, Unichem Laboratories said in a regulatory filing.
A form 483 is issued by the US FDA to notify a company’s management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.
Shares of Unichem Laboratories were trading 2.63 per cent higher Rs 183.50 apiece on the BSE.