rare disease

Clinical Inspection Summary of Wellstat Therapeutics Xuriden (uridine triacetate)

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Xuriden (uridine triacetate). Two sites plus the sponsor were inspected.

The first site enrolled two subjects and received a 483 for inadequate/inaccurate records, specifically:

  • The Day 28 administration time recorded by the site was 7:55 AM and the administration time recorded by the parent in the log was 7:45 AM for one subject.
  • The Day 28 dosing time recorded on the CRF for another subject had been changed from 8:30 AM to 8:43 AM, despite the lack of supporting source documentation. FDA notes that the dosing time had not been recorded by the study nurse, as there was no place to record this information. It was noted that the parent log contained an entry for 8:30 AM, but review of the PK lab requisitions indicated that dosing occurred at 8:43 AM.

The second site enrolled two subjects and received a 483 for inadequate investigational product accountability, specifically:

  • One hundred sixty sachets of drug were dispensed to each subject. Each subject should have used 117 sachets. Records onsite indicated that each subject returned 126 sachets. The Principal Investigator responded that the pharmacy compared drug accountability logs with the drug administration diaries and the revised count was 106, but due to partially used sachets being combined, the counts were not precise.