 "Cadila Healthcare's Baddi unit receives 3 observations under Form 483")
Following an inspection by the US Food & Drug Administration (FDA) from February 20, 2017 to March 1, 201, Cadila Healthcare’s formulations manufacturing facility at Baddi (Himachal Pradesh) has received three observations given under Form 483 from the US dug regulator. All these three observations are related to pre-approval inspection (PAI) for a specific product filed.
“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. Apart from above product related observations, there are no observations related to cGMP practices,” said the company in a BSE filing.
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