The company said it 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.
On Wednesday, the stock ended 6% lower after the drug maker confirmed that its Halol facility had undergone an inspection by USFDA recently.
The USFDA inspected the Company's Halol facility in Gujarat, India from November 17, 2016 through December 1, 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,” Sun Pharma said in a BSE filing today.
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