Brigham and Women’s Hospital Inc.

Selected passages from the FDA letter

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

Passage 1

You failed to provide adequate facilities for the prevention of contamination.

Passage 2

Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications. (21 CFR 212.20(d)).

Passage 3

You failed to conduct adequate investigations into multiple out-of-specification (OOS) endotoxin results, including implementing appropriate and effective CAPAs.

Passage 4

Failure to address violations 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 violations 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 violations.