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Divi’s Laboratories gets 6 Food and Drug Administration observations for Vizag unit
City-based Divi’s Laboratories has received six new observations from the US Food and Drug Administration (USFDA) after inspection of its unit-2 located at Visakhapatnam in Andhra Pradesh. The observations were procedural, says the drug maker. However, it did not elaborate on them.
Hyderabad: City-based Divi’s Laboratories has received six new observations from the US Food and Drug Administration (USFDA) after inspection of its unit-2 located at Visakhapatnam in Andhra Pradesh. The observations were procedural, says the drug maker. However, it did not elaborate on them.
USFDA inspected Unit-2 of the company during September 11-19, 2017. Divi’s Laboratories in a communique to BSE, said: “On completion of this inspection, we have received a Form 483, citing six observations which are procedural and the company will be responding to these within the stipulated time. The inspection was for full cGMP and verification of all corrective actions proposed against the previous inspection observations. All previous observations have been confirmed as completed and resolved.”
A Form 483 issued by the USFDA notifies the company’s management of objectionable conditions at its facility. It is issued at the conclusion of an inspection “when an investigator (s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”
