“At the conclusion of the inspection, the USFDA issued a Form 483, with one observation for which the company has submitted the response,” it added.
As per the USFDA, an FDA Form 483 is issued to a firm’s management at the conclusion of an inspection “when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”
The Baska injectibles plant had recently filed for approvals to sell its products in the US, which is currently Sun Pharma’s biggest market. The manufacturing plant is located near the company’s Halol plant which is already facing regulatory issues from the US health regulator.
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