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Sun Pharma on Tuesday said the U.S. health regulator has issued a ‘Form 483’ with ten observations after inspecting its Halol-based manufacturing plant in Gujarat.
As per U.S. FDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The U.S. Food and Drug Administration conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, the Mumbai-based drug maker said in a regulatory filing.
“At the conclusion of the inspection, U.S. FDA issued a Form-483, with 10 observations. The company is preparing the response to the observations, which will be submitted to the U.S. FDA within 15 business days,” it added.
The company is committed to addressing the observations promptly, Sun Pharma noted.
It remains committed to working closely with U.S. FDA and continues to enhance its GMP compliance on an ongoing basis, it added.
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