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Cadila Healthcare said that it has received three observations from USFDA for its formulation facility at Baddi, Himachal Pradesh.
From February 20 to March 1, the USFDA has inspected the plant.
The company has said in a press release that “All these three observations are related to pre-approval inspection (PAI) for a specific product field.”
It further said that “The product is yet to be manufactured or marketed in the US.”
It has said that the company is already in the process of responding to the PAI observations.
It has also clarified that apart from products related observations, there were no observations related to current good manufacturing practices (cGMP).
