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On December 7, 2016, the US Food and Drug Administration (USFDA) had issued form 483 with five observations against Divi's Laboratories' unit at Chippada Village in Visakhapatnam of Andhra Pradesh. The USFDA inspected the company’s unit from November 29, 2016 to December 6, 2016.
These critical observations will be responded within the time permitted, the company said in a statement.
Form 483 relates to certain critical observations issued to a company at the end of an inspection if there were any violations of the Food Drug and Cosmetic Act and other related acts of the US Government.
Divi's manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at this plant.
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These critical observations will be responded within the time permitted, the company said in a statement.
Form 483 relates to certain critical observations issued to a company at the end of an inspection if there were any violations of the Food Drug and Cosmetic Act and other related acts of the US Government.
Divi's manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at this plant.
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