The FDA has thrown down the gauntlet, so to speak, over problems it found at a plant in India that Mylan ($MYL) is buying from Strides Arcolab. Among many other problems FDA inspectors tallied in a warning letter, it chastised the management of the Agila Specialties plant for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.
In the letter posted Tuesday, the FDA said the plant's quality-assurance group handed out the gloves even though they had visible holes and were discolored and flaking. "These defective gloves are especially concerning in part because they were used to perform manipulations directly over empty vials," the letter said. The agency acknowledged that the company said it would find a different glove supplier but said, "Your written response minimizes the importance of ensuring glove integrity and its potential impact on product quality."
Other issues the Bangalore plant was criticized for included poor environmental monitoring in the aseptic processing area and issues with its filling procedures. "Please note that no amount of successful media fills can be used to validate poor aseptic design, operations, controls, and practices. Sterility assurance requires a holistic approach in every aspect of the aseptic operations," the warning letter pointed out.
There were concerns about the same mop being used throughout production and stored outside the aseptic processing area before reuse, as well as the lack of controls to prevent the deletion of data on HPLC equipment. There was standing water in the cold storage area and mold on finished product shipping containers.
Strides reported last week that it had received the warning letter and said it was responding to problems but didn't give details of FDA concerns. The plant is part of the Agila Specialties unit that specializes in sterile injectable drugs that Mylan has agreed to buy for about $1.6 billion. A Mylan spokesperson said the company knew about the letter and the issues at hand and that the action would not jeopardize the deal. "Based on what we know today, we continue to expect to close the Agila acquisition in Q4 2013 and do not expect that the matter will have a material impact on our financial assumptions with regard to our combined business," a company spokesperson told the PTI news service in an email.
- here's the warning letter