Sun Pharmaceutical Industries’ Halol facility in Gujarat has inspected by the US Food and Drug Administration (USFDA) from November 17, 2016 to December 1, 2016. The company has been issued a Form 483, citing nine inspectional observations. None of those observations were characterized by the USFDA as repeat observations. The company is preparing its responses to the observations, which will be submitted to USFDA within 15 business days of receipt of the Form-483. The company intends to implement promptly any corrective actions and improvements that may be necessary as a result of the observations and to continue to work cooperatively with USFDA.
Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
