obiltoxaximab

FDA Clinical Inspection Summary: Anthim (obiltoxaximab) by Elusys Therapeutics

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 Anthim (obiltoxaximab) submitted by Elusys Therapeutics. Inspections covered five studies conducted at six clinical sites. Inspections covered 3 to ten days. One site, Quintiles Phase One Services in Overland Park, Kansas received a 483; however the entire 3.5 pages of the 483 are completely redacted. Unredacted information for the other clinical site inspection indicates that the following topics were discussed with FDA:

  • Covance Clinical Development in Daytona, FL was questioned as to why the Steering Committee for the study did not evaluate blinded safety information in the timeline specified by the protocol before additional subjects were dosed. The firm was able to demonstrate that data was provided to the committee in a timely fashion and that a protocol deviation had been filed.
  • Covance Clinical Research Unit in Madison, WI was asked by pre-dose fasting times were not clearly defined in the protocol.
  • Covance Clinical Research Unit in Evansville, IN had no findings or discussion items as a result of the inspection at that location.
  • Quintiles in Overland Park received a 483 for failing to follow the investigational plan. The three and half pages describing the specifics of this have been redacted. 
  • Covance Clinical Research Unit in Dallas, TX had the following discussion items:
    • Temperature probes on freezers where samples were stored were out of range
    • Written SOPs and WIs were not followed (daily check of emergency equipment, not all dosing sheets were initialed and dated by the investigator, the atomic clock specified by SOP for ECG time recording was not used, not all source docuemnts were checked in a timely manner)
  • Davita Clinical Research in Minneapolis was inspected. The discussion items from that inspection were:
    • No objective evidence that IV bags had been labeled according to the protocol
    • Not all dose preparations were checked by a second person