Unichem Laboratories said the US FDA has completed its inspection of the company’s formulations manufacturing facility in Goa.
The facility has received an Establishment Inspection Report, the company added.
“This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has now been closed by the USFDA,” it said.
The US FDA carries out periodic inspections of facilities of manufacturers who are permitted to sell their drugs in the United States.
Unichem Labs’ inspection was carried out between March 14, 2017 to March 20, 2017.
Unichem Laboratories manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and across the world.
In India, the company focuses on cardiology, neurology, orthopedics and anti-infectives.