Gets issued Form-483 with 9 observations
Sun Pharmaceutical Industries announced that the USFDA inspected the Company's Halol facility in Gujarat, India from 17 November 2016 through 01 December 2016. At the conclusion of the inspection, the USFDA 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.Powered by Capital Market - Live News
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