FDA investigators, particularly in India, have learned it is best to look beyond the production floor, clean rooms and quality control labs when doing inspections. They look around shredders, in trash cans and even barrels in factory scrap yards.
That is where they found drug testing records at a Strides Pharma plant, according to a warning letter posted by the FDA Tuesday.
Inspectors also found records in bags awaiting shredding. They all were discarded without being reviewed by quality control staff, some just a week before the FDA arrived for its inspection. The agency is not pleased.
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“The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your QU and the integrity and accuracy of your CGMP records,” says a warning letter issued to the facility in Puducherry, India.
The company in a statement today said it is “committed to the highest standards of quality and compliance” and will work with the FDA to resolve all issues. It acknowledged that approvals for 10 pending generic drug applications will be deferred until the plant is in compliance, but said six approved drugs the plant produces for the U.S. market will be unaffected by the FDA actions.
The FDA said Strides' commitment to quality has not been evident to date. It said it clearly needs to get a consultant that can help it learn and follow FDA standards.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the warning says.
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While Indian drugmakers have made big strides on quality in the last few years, the FDA has run across these kinds of efforts to hide data before. Wockhardt, Hetero Labs, Megafine and USV have all received warning letters citing instances in which records were headed for a shredder in an apparent effort to hide test results raising questions about the quality or effectiveness of their drugs.
Some companies have taken obfuscation much further. In 2015, Dr. Reddy’s Labs was flayed in a warning letter for having had a hidden laboratory where tests could be conducted and test results discarded if they didn’t meet standards.
Before that, employees of a Fresenius plant in India confessed to an FDA inspector that employees had removed high-pressure liquid chromatography equipment and computers ahead of inspections so investigators wouldn't learn the plant had been manipulating data to get passing levels. The 2013 letter said Fresenius "repeatedly delayed, denied, limited or refused to provide information to the FDA investigators."