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Divis Labs gets 6 USFDA observations for Vizag unit

Divis Labs gets 6 USFDA observations for Vizag unit

New Delhi: Drug firm Divis Laboratories on Thursday said it has received six new observations from the US Food and Drug Administration (USFDA) after inspection of its unit two at Visakhapatnam.

The Hyderabad-based drug maker said the observations were procedural. It, however, did not elaborate on them.

Unit 2 of the company at Visakhapatnam has been inspected by USFDA from September 11 to September 19, 2017, Divi’s Laboratories said in a filing to BSE.

On completion of this inspection, the company “has received a Form 483, citing six observations which are procedural and the company will be responding to these within the stipulated time”, it added.

The inspection was for full cGMP and verification of all corrective actions proposed against the previous inspection observations, Divi’s Laboratories said.

“All previous observations have been confirmed as completed and resolved,” it added.

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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts”.

Earlier in July 2017, Divi’s Laboratories had said that US health regulator will lift an import alert imposed on the company’s Unit-II at Visakhapatnam.

The company “has been informed by the USFDA that it will lift the import alert 99-32 imposed on the company’s Unit-II at Visakhapatnam”, it had said in a regulatory filing.

Divi’s Laboratories had been issued a warning letter by the US health regulator earlier this year for its Visakhapatnam facility and had been issued import alert by the USFDA in March 2017 for the facility.

In the warning letter, USFDA had raised concerns such as data integrity issues, including failure to prevent unauthorized access to laboratory records among issues for the letter.

Source: PTI
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