Biogenerix AG

FDA Clinical Inspection Summary: Neutroval (XM02) submitted by Teva Pharmaceuticals

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 Neutroval (XM02) submitted by Teva Pharmaceuticals. Two sites, the sponsor (Biogenerix AG) and a CRO were inspected. Site inspections lasted 3-5 days. Both sites and the sponsor were issued FDA Form 483s.

Dr. Zabarskaya was cited for the local lab using hematology analyzers to analyze samples where the results report stated that the reagents used may be expired. 

Dr. Makhson received a citation for failing to have on file documentation indicating that quality control procedures for the hematology analyzers were in place for two years during the study. 

Biogenerix AG was inspected in conjunction with the CRO and was cited for:

  • Failing to conduct the investigation according to the investigational plan, specifically:
    • There were no written records to support unlocking the database twice following unblinding (including a lack of date for the second unlocking) by the CRO
    • Sponsor approval was not obtained for unlocking the database as required by SOP (note the Form 483 was issued to the sponsor)
    • Failing to have a CRO signature on the first unlock form (note this was in the 483 issued to the Sponsor)
    • No database unlock form was available for the second unlock
    • A project manager signature was added to one of the unlock forms retrospectively and backdated with an explanation
    • Database quality control forms were not maintained as required by SOP, including QC checks and randomization for final QC checks