The USFDA has made nine ‘observations’ highlighting violations of its norms at homegrown drug maker Wockhardt’s new facility at Shendra in Aurangabad.
The company, whose shares slumped 15.04 per cent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US.
“Inspection of our manufacturing unit at Shendra, Aurangabad by USFDA has since been completed.
USFDA has made nine observations for which appropriate reply would be submitted to the inspecting authority in due course,” Wockhardt Ltd said in a regulatory filing.
Without disclosing details of the observations, it further said: “The Shendra manufacturing unit is a new facility and presently there are no supply of products from the said unit to the US markets.”
The observations were made by the USFDA in the form of Form 483, which is issued to a company management at the conclusion of an inspection, highlighting any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related laws.
It emerged yesterday that 62,555 bottles of anti-biotic Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market.
The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles).