Dr Reddy's unit fails to clear US FDA audit

The US drugs regulator had issued a warning letter to three of firm manufacturing facilities

Dr Reddy’s Laboratories on Tuesday informed the stock exchanges the US Food and Drug Administration (US FDA) had made three adverse observations with a Form 483, after completing an audit of its active ingredients (APIs) manufacturing facility at Miryalaguda in Telangana.

According to the FDA, “Form 483 is issued to firm management 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”. It notifies the company’s management of objectionable conditions.

The US drugs regulator had issued a warning letter to three of Dr Reddy’s manufacturing facilities, including the Miryalaguda plant, in November 2015 after it had found some serious quality control issues and other deviations. The warning letter came after the drug regulator was not satisfied with the corrective steps taken by the company over the initial Form 483 observations issued against these facilities in early 2015.

Late last year, the company had announced that it had completed the remediation work at all the three facilities and had also requested the US drug regulator to re-audit the facilities. Last month the company said it was expecting the re-inspection of all the three facilities during the February-March period. 

The audit of the Miryalaguda facility was a part of the re-inspection undertaken by the drug regulator.

The issuance of Form 483 has come as a big surprise to the management. The company had reworked the architecture of quality practices across all the manufacturing plants in a bid to avoid any further setbacks. 

“We have been issued a Form 483 with three observations, which we are addressing," the company stated in its filing. It was not clear how serious these observations were or the nature of the observations.

The fresh observations call for fresh round of steps to address the issues raised by the US FDA inspection team and this would mean that it would take more time before the regulator leaves the concerned manufacturing plants off the hook.