FDA Clinical Inspection Summary: Cysview Kit (Hexaminolevulinate hydrochloride) submitted by Photocure ASA

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 the Cysview Kit (Hexaminolvulinate hydrochloride) submitted by Photocure ASA. Three sites plus the sponsor were inspected. Site inspections lasted from two to four days. The sponsor inspection lasted four days. One site plus the sponsor received a FDA Form 483.

Dr. de Reijke was cited for:

  • Two subjects were treated with prohibited concomitant medications. FDA notes that the CRO did not record these events as protocol deviations.

Photocure was cited for failing to properly monitor the study per 21 CRF 312.56, specifically:

  • Failing to monitor one site at the frequency defined in the monitoring plan. FDA notes that a single visit was missed, resulting in one out of window visit. 

Although not cited on the FDA Form 483, the following issues were noted on the establishment inspection report from the sponsor inspection:

  • Two sites did not always conduct biopsies of lesions as required per protocol, preferring alternate means of assessing the lesions.
  • Two sites administered prohibited chemotherapy agents. FDA notes the exclusion of these subjects from the study per protocol analysis.
  • Failure to videotape study procedures as required per protocol.
  • Failure to have study follow up visits per protocol at one site.
  • Failure to document all risks in the informed consent at three sites.
  •  Failure to specify in the informed consent that videotaping would occur as part of study procedures.
  • Failure to use an updated informed consent for ten subjects at one site describing the videotaping.