Violation Without Intent?

Generic drug maker Apotex has received several FDA Warning Letters in recent years, with the latest being sent at the end of January 2015 (1). The letter stems from an FDA inspection conducted in June/July 2014. Apotex has already responded to the FDA’s inspection observations seven times, but the FDA is not satisfied with the replies or proposed corrective actions. In fact, the letter states that some of the explanations raise “further issues.”

The problems noted in the Warning Letter relate to one of the company’s plants in Bangalore, India, where there were issues in data integrity practices, including disregarding “trial” test results, missing test plates, and a lack of oversight over laboratory computer systems. “Trial” sample testing was also noted in January 2014 during an FDA inspection of another Apotex plant in Bangalore. In the latest warning letter, the FDA says that the “inspection of your facility documented multiple incidents of performing ‘trial’ testing of samples, disregarding test results, and reporting only those results from additional tests conducted.”

With FDA investigators noting instances where quality control personnel created unauthorized folders on laboratory computerized systems, the letter makes it clear that Apotex’s response leaves much to be desired, “In correspondence with the Agency, you indicate that no malicious data integrity patterns and practices were found. Also, you state that no intentional activity to disguise, misrepresent or replace failing data with passing data was identified and no evidence of file deletion or manipulation was found. Your response and comments focus primarily on the issue of intent, and do not adequately address the seriousness of the cGMP violations found during the inspection.” The company’s investigation into a number of missing test plates also failed to impress the Agency. According to the letter, the company claims that “two analysts momentarily panicked” and removed the plates “in an utterly misguided and ill-conceived attempt to clean up the microbiology lab prior to the start of the FDA inspection.” Apotex is working with a third-party consultant to conduct a comprehensive audit of the company’s systems and data integrity.

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