Dr Reddy's facility fails to clear the inspections by USFDA yet again

The Duvvada (Visakhaptanam) sterile injectables facility of drug major Dr Reddy's Laboratories Limited has again been issued a Form 483, this time with 8 observations, by the team of US Food and Drug Administration(USFDA) at the end of the reinspection conducted at the request of the company.

"The audit of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the USFDA, has been completed today. We have been issued a Form 483 with 8 observations, which we are addressing," the company said in a filing.

The fresh round of concerns raised by the USFDA inspectors over the Oncology formulations facility comes as a big set back to the company. In November 2015 US FDA had issued a warning letter to the company after finding serious quality related deviations at three of Dr Reddy's manufacturing facilities. 

Two of these three facilities, including the Duvvada plant and the API manufacturing facility in Srikakulam, faced similar adverse outcomes with varied number of inspectional observations in the past three years despite the remediation measures were implemented by the company. 

The third facility, an API manufacturing plant located in Miryalaguda of Telangana was cleared by the USFDA inspectors during a reinspection in June last year. 

Duvvada and Srikakulam plants will continue to face the import ban because of the warning letter, which would be withdrawn by the US drug regulator only if they clear the test of reinspection without any fresh observations.