FDC receives US FDA's positive inspection report for Baddi plant

FDC Ltd has received the establishment inspection report (EIR) from US Food and Drug Administration (US FDA) for its manufacturing unit situated at Baddi (Himachal Pradesh) with ‘no observations’. “This approval confirms the closure of inspection conducted in February 2016. The said audit was carried out in relation to cGMP inspection and ANDA filed by the company for product cefixime 400 mg tablet,” said FDC Ltd in a BSE filing on July 2, 2016.
 
Meanwhile, FDC, the manufacturer of pharmaceutical formulations and bulk drugs, announced that it has received two minor observation from US FDA for its manufacturing facility at Waluj (Aurangabad, Maharashtra). “Inspection of the company’s manufacturing unit situated at Waluj, District- Aurangabad, Maharashtra, by US Food and Drug Administration has been completed on July 01, 2016. The US FDA has made two minor observations for which appropriate steps shall be taken by the company,” the company added.
   
US FDA carried out audit in relation to cGMP inspection and ANDA filed by the company for product dorzolamide ophthalmic solution.