New Delhi : Drug firm Cadila Healthcare said the US health regulator has given three observations after completing inspection of the its facility at Baddi in Himachal Pradesh.
“The United States Food and Drug Administration (USFDA) inspected our formulations manufacturing facility at Baddi from February 20, 2017, to March 1, 2017,” Cadila Healthcare said in a filing to stock exchange BSE.
“At the end of the inspection, there were 3 observations given under form 483, it added.
All these observations are related to pre-approval inspection (PAI) for a specific product filed, Cadila Healthcare said without naming the product.
“This product is yet to be manufactured or marketed in the US. The company is already in the process of responding to the PAI observations,” it added.
Apart from the particular product related observations, there are no observations related to cGMP practices, Cadila Healthcare said.