Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data and paper records. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards.
Our investigators found that your firm routinely retested samples without justification and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs. You are responsible for determining the causes of these deviations, for preventing recurrence,and for preventing other deviations from CGMP.