Sun Pharma site hit with second Form 483 in 3 years
An Indian pharma with a manufacturing site in Gujarat has been slapped with a Form 483 from the FDA after inspections that ended yesterday resulted in 10 observations.
The inspection was carried out from April 26 to May 9 at Sun Pharma’s Halol facility in Gujarat, and shares were down 3% following the release of the news. The details of the observations have not yet been revealed.
“The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days,” Sun Pharma said in a letter to the National Stock Exchange of India. “The company is committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis.”
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