Galena Hit With 10-Item Form 483 Over Unresolved Issues
The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility.
During the Aug. 17 to 25 inspection, investigators found that ADE information was not reported to the FDA, including for a serious and unexpected incident involving Galena’s breakthrough cancer pain treatment Abstral (fentanyl). The firm also failed to conduct follow-up investigations on at least two ADEs related to the opioid drug.
Galena didn’t have written procedures on evaluating, processing and reporting ADEs until last December, and there’s no documentation that the firm retrospectively reviewed all events that are subject to 15-day alerts, the 483 says. The form notes that at least nine serious and unexpected ADEs were not reported in time.
The 483 also dings the drugmaker for failing to develop written procedures for reporting postmarketing ADEs to the FDA and for incomplete and inaccurate information in periodic safety update reports.
Further, investigators found several repeat observations from a November 2014 inspection related to the failure of Galena’s quality unit to ensure that written responsibilities and procedures for risk assessment, use of electronic signatures, annual product reviews and IND safety reporting were fully followed. The FDA issued a warning letter in April citing those and the ADE concerns.
Galena CEO Mark Schwartz saysthe firm “has resolved the prior manufacturing issues, taken steps to ensure comprehensive reporting of AEs, and [is] working to address all aspects of our reporting systems.”
Read the Form 483 at www.fdanews.com/10-15-15-Galena.pdf. — Tamra Sami