Fagron Group B.V.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to perform repackaging of API under appropriate CGMP to avoid potential cross-contamination.

Passage 2

Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions.

Passage 3

Failure of your quality unit to exercise its responsibility to ensure the API manufactured at the facility are in compliance with CGMP.

Passage 4

Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of any 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 your corrective actions.