The United States Food and Drug Administration has issued a "Form 483" with 10 observations to Sun Pharmaceutical Industries Ltd. after inspecting the drugmaker's Halol-based manufacturing plant in Gujarat.
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 judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
The US FDA conducted a good manufacturing practices inspection of the Halol facility from April 26, 2022, to May 9, 2022, Sun Pharma said in a regulatory filing on Tuesday. "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 U.S. FDA within 15 business days," the company stated in the filing.
Sun Pharma said it is working closely with the U.S. FDA and is committed to addressing the observations promptly, and continues to enhance its GMP compliance on an ongoing basis.
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