Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to ensure that equipment surfaces in contact with raw materials, intermediates and API do not alter the quality of the intermediates and API beyond the official or other established specifications.
Passage 2Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications.
Passage 3You failed to conduct adequate investigations into out-of-specification (OOS) results. For example:
Passage 4Failure 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.