When Dr. Reddy's ($RDY) acknowledged last month that it had received a warning letter for three of its Indian plants, it proclaimed it was "actively engaged" with the FDA to resolve the issues. But an FDA warning letter posted last week says that even after the company responded 9 times to the host of observations, the agency has not been assured it is on top of serious problems which included the discovery of a previously undisclosed testing lab.
The country's third largest drugmaker reported in November that active ingredient plants in Srikakulam and Miryalaguda, as well as its Oncology Formulation manufacturing facility at Duvvada, were all named in the letter. The citation came after the FDA did an inspection sweep in November 2014 and then in January and February of this year.
The FDA said that while inspecting a Dr. Reddy's API plant in Srikakulam, an employee told an inspector about an "uncontrolled Custom QC laboratory" the company had used through 2012 for testing APIs it was shipping to the U.S. Inspectors discovered records in the lab that indicated Dr. Reddy's had repeatedly tested APIs for impurities, never recording failed tests, and then put into records shown the agency only those instances in which batches had passed.
Inspectors also reported other examples at that plant and an API plant in Miryalaguda where supervisors were not keeping control over equipment and plant employees had apparently changed or destroyed some records. One analyst blamed record changes and deletions on an "unknown individual" said to have logged on to the computer using the analyst's credentials.
At Dr. Reddy's Oncology Formulation manufacturing facility at Duvvada, inspectors raised issues about the potential for contamination in the way that employees handled vials of sterile injectable drugs. They reported there were no standards to insure drugs met specs for strength, quality, and purity and that employees were often not trained in how to determine which vials should be kept and which rejected.
Dr. Reddy's joins a growing list of India's top drugmakers to whom the FDA has issued warning letters or instituted product bans. That includes the country's largest, Sun Pharmaceutical and Ranbaxy Laboratories, which Sun now owns, as well as Wockhardt and others.
- here is the warning letter