New Delhi: Drug firm Unichem Laboratories said the US health regulator has made four observations after inspection of its active pharmaceutical ingredient (API) manufacturing facility at Roha in Maharashtra.
The Roha facility was inspected by the United States Food and Drug Administration (USFDA) from July 30, 2018, to August 03, 2018, Unichem Laboratories said in a filing to the BSE.
“Four observations were made which do not impact continuity of the company’s business and its manufacturing activity,” it added.
The company proposes to respond to these observations within 15 business days, Unichem Laboratories said.
“The Roha facility manufactures API for use in the production of formulations that are exported to the USA,” it added.
As per the USFDA, observations are made to a company’s management after inspection of a facility in Form 483. An FDA Form 483 notifies the company’s management of objectionable conditions.