Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to perform repackaging, relabeling, or holding of API under appropriate CGMP to avoid mix-ups and loss of API identity or purity.
Passage 2Your firm failed to have adequate controls to prevent cross-contamination between API. Your functions included receipt, storage, weighing, repackaging, and relabeling of API in the same room using non-dedicated equipment and without appropriate procedures.
Passage 3Failure to adequately establish written procedures for cleaning equipment and its release for use in manufacture of API and validate written procedures for the cleaning and maintenance of equipment.
Passage 4Your firm failed to establish adequate written procedures for cleaning non-dedicated production equipment used for your API, some of which were highly potent. In addition, you failed to document the usage and cleaning of repackaging equipment. For example, you did not document equipment used or whether cleaning was performed after repackaging a cytotoxic drug, Lomustine (lot **(b)(4)**), on or around April 9, 2020.
Passage 5Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.
Passage 6Failure 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.