Unichem Laboratories has got two observations from USFDA for its formulation facility at Ghaziabad, Uttar Pradesh.
The US drug regulator has inspected the facility from February 24 and March 3.
Unichem has said in a statement that “The two observations cited are, in the opinion of the company, correctable ones in respect of which the company will file the necessary response within the stipulated period of 15 working days.”
It added that “The observations do not impact business continuity and the company’s supplies to the US market.”
