DRL kept us in dark on lab: FDA

“During the inspection, the presence of an uncontrolled “Custom QC laboratory” (CQC) was discovered by our inspection team. The existence of this laboratory was previously unknown to FDA. Your QC associate director acknowledged that the CQC laboratory was involved in CGMP analysis of APIs intended for export to the United States through 2012,” said a warning letter issued by US FDA on November 5.

According to the letter, the discovery of the unnotified QC laboratory was made one day before the end of the inspection. FDA also warned the company that failure to rectify the deviations could lead to a ban on its products made at its three plants in Andhra Pradesh and Telangana State.

Dr Reddy’s spokesperson, however, refused to comment on the matter. At the same facility, the letter claims that FDA inspectors have also fou-nd that “batch samples were routinely re-tested following failing or atypical results until acceptable results were obtained.” At Dr Reddy’s Nalgonda facility in Telangana, FDA claimed that the company allowed its staff to deviate from current good manufacturing practices (CGMP).

“During the filling operation, our investigator observed an operator repeatedly using forceps and hand to... align the conveyor belt. The operator intervened again to put the [batch] onto the conveyor belt. Because the conveyor belt was not operational, an operator manually intervened to [take] the vials into the loading area,” the letter by Food and Drug regulator explained.

The US drug regulator said that each of these manual interventions risks compromising the sterility of the product and is a deviation from your approved CGMP. Citing Dr Reddy’s Labs’ response which claimed this particular incident as a unique and a ‘one off’ failure which has not occurred in the past,” the regulator said “your conclusion that potential effects on sterility were remote is unjustified.”