Sun Pharma said on Tuesday the US Food and Drug Administration issued a “Form 483” with 10 observations after inspecting its halol-based manufacturing facility in Gujarat.
According to the US FDA, a company’s management is issued a Form 483 upon completion of an inspection if the inspector has identified conditions that it believes may violate the Food Drug and Cosmetic (FD&C) Act and related laws.
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 drugmaker said in a regulatory filing.
“At the end of the inspection, the US FDA issued a Form 483 with 10 observations. The company is preparing the response to the observations to be submitted to the US FDA within 15 business days,” she added.
The company is committed to promptly addressing the observations, Sun Pharma noted.
It will continue to work closely with the US FDA and continuously improve its GMP compliance, it added.
