New Delhi: Drug firm Cipla said it has received observations from the US health regulator for its Goa plant which are procedural in nature.
The United States Food and Drug Administration (USFDA) had conducted a product-specific pre-approval inspection at company’s Goa plant in January 2018, Cipla said in a BSE filing.
“We received certain observations which are procedural in nature. We have already responded to the agency on all the observations,” it added.
At this stage, the company does not foresee any impact on the other products being manufactured/filed from the plant, Cipla said.
“Post this inspection, we have received 2 product approvals from the plant,” it added.