Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.
Passage 2Failure of your quality unit to ensure that drugs are appropriately tested and the results are reported.
Passage 3Failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the particular operations that each employee performs and CGMP as they relate to the employee’s functions.
Passage 4You failed to ensure that laboratory personnel who performed CGMP testing were adequately trained in current good manufacturing practice requirements. CGMP testing is performed by both faculty members and graduate students at your facility. Your firm lacked the adequate documentation to demonstrate that laboratory personnel were adequately trained in their respective job functions.
Passage 5Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.