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.