For the second time in about six weeks, India’s Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with the problems the agency had outlined in a warning letter two years ago.
In a filing Tuesday, India’s second-largest drugmaker said (PDF) that the FDA issued a Form 483 with two observations during a return visit to its API plant in Srikakulam. The drugmaker gave no indication of the nature of the observations but said it was addressing them.
The Srikakulam plant figured prominently in the three-plant warning letter the FDA issued to Dr. Reddy’s in 2015. It was there that investigators learned the company had a previously undisclosed quality-control lab. For years Dr. Reddy's had repeatedly tested APIs for impurities in the secret lab and not recorded failed tests, only reporting results that showed batches had met specifications.
The new Form 483 is a repeat of what happened in February when the company said the FDA had revisited its API plant in Miryalaguda and issued a Form 483 with three observations.
In that warning letter, the FDA cited management at the Miryalaguda plant for failing to control equipment and records to prevent testing data from being changed or destroyed, which it said employees at that plant had been doing, among other issues.
The third facility cited in the warning letter was Dr. Reddy’s Oncology Formulation manufacturing facility at Duvvada, where in 2015, inspectors raised a number of issues about the potential for contamination in the way that employees handled vials.