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Divi's Vizag unit gets form 483, five observations from USFDA

The company should respond to form 483 in writing with corrective action plan, then implement that expeditiously

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Sharath Chowdary Hyderabad
Last Updated : Dec 07 2016 | 8:44 PM IST

The US Food and Drug Administration (USFDA) has issued form 483 with five observations against Divi's Laboratories' unit at Chippada Village in Visakhapatnam of Andhra Pradesh following an inspection, which concluded on December 6.

These critical observations will be responded within the time permitted, the company said in a statement on Wednesday.

Form 483 relates to certain critical observations issued to a company at the end of an inspection when if there were any violations of the Food Drug and Cosmetic Act and other related acts of the US Government.

The company should respond to the form 483 in writing with their corrective action plan and then implement that expeditiously.

Divi's manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at this plant.

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First Published: Dec 07 2016 | 8:20 PM IST

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