India’s largest drug maker Sun Pharma on Monday said that it has received letter 483 (an observation of deviation in manufacturing practice) from the US Food and Drug Administration for its manufacturing plant in Baska Gujarat.
Sun said it has received 1 observation for this facility and the company has subsequently submitted its response to the regulators. The US FDA conducted a Pre-Approval Inspection (PAI) of Sun Pharmaceutical Industries Ltd.’s Baska facility (Gujarat) from January 28 to February s, 2019. At the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to the US FDA. There is no material impact of this article on the Company”, the company said in a statement to the exchanges. Shares of Sun Pharma on Monday fell by 2% on the reports of FDA inspection. The company’s stock price ended at Rs 464 down by 1.89%.