Actavis

FDA Clinical Inspection Summary: Avycaz (Avibactam sodium; ceftazidime)

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Avycaz (Avibactam sodium; ceftazidime) submitted by Cerexa. Four sites, the sponsor and the CRO were inspected. Site inspections ranged from three to thirteen days and the sponsor inspection took place over fifteen days. The inspection of the CRO was based on problems with the IVRS managed by the CRO during the study. Two sites plus the sponsor received FDA Form 483s.

Dr. Patzan was cited for:

  • Failing to conduct a clinical investigation according to the investigational plan, specifically:
    • Enrolling three subjects who met exclusion criteria
    • Failing to report three adverse events to the sponsor (depression, facial edema and rash)
  • Failure to prepare and maintain adequate and accurate case histories
    • The subject diaries and drug accountability logs for five (of fifteen patients) contained discrepancies.

Dr. Bibi was cited for: 

  • Six subjects were enrolled despite meeting exclusion criteria
  • Two subjects were enrolled without the PI reviewing screening/eligibility laboratory values

The sponsor, Actavis, was cited for:

  • Failing to retain records, specifically:
    • The sponsor failed to retain all shipping records for drug product to eleven clinical sites
    • Failing to retain ten monitoring visit reports
    • Failing to follow the investigational plan, specifically nine monitoring visit reports were not signed off in the required timeframes
  • Failing to ensure proper monitoring of the study
    • The original sponsor of the study did not identify issues with the IVRS system failing to properly allocate drug to 28 of 33 clinical sites

 

 

FDA Clinical Inspection Summary for Viberzi (eluxadoline) by Furiex Pharmaceuticals

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators, From the archives, here is the Clinical Inspection Summary for eluxadoline, originally submitted by Furiex and now marketed by Actavis as Viberzi. Five sites, plus the sponsor and the CRO who provided the IXRS system for the study were inspected. Sites were selected for inspection on the basis of high enrollment, previous inspections, complaints and efficacy results. Inspections spanned three to twelve days. Two sites received 483s.

 

Dr. Alterbaum received a 483 for failing to follow the investigational plan and failing to report study changes to the IRB.

  • During the course of the study, a monitor determined that study staff was entering data that was required to be entered by the subjects.
  • FDA notes that Dr. Alterbaum removed the study staff, discussed the issue with the subjects and instituted corrective action. 

Dr. Wilson received a 483 for enrolling an ineligible subject.

  • A subject with an exclusionary lab value was enrolled. FDA notes that this was a known issue, and reported in the NDA line listings that the sponsor had submitted to FDA.