Divi’s Laboratories receives form 483 with 5 observations

Hyderabad based drug major, Divi’s Laboratories in an exchange filing informed of receiving a form 483 with 5 observations for the inspection carried out by the US healthcare regulator for company’s Unit-II at Visakhapatnam, Andhra Pradesh.

Company in a statement also said that they will be responding to the raised observation within the stipulated time frame.

An FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute towards violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Company’s stock is likely to remain in focus when it opens for trade on Thursday, December 8. Shares are likely to see a huge negative to its prices when it opens. Of late Pharma companies have witnessed knee jerk reactions to similar news pertaining to regulatory observations.

Shares of Divi’s Laboratories closed at Rs 1163.60, up close to one per cent on BSE.