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 Oxytrol for women (oxybutynin) submitted by Merck Consumer Care. Three sites were selected for inspection, based on enrollment, serious adverse events and study discontinuations. Inspections ranged from 3 to 4 days. One site received a FDA Form 483.
The pharmacy at site #12 was cited for:
- Failing to obtain proper informed consent, as nine subjects were not reconsented to the most recent IRB approved consent form.
- Failing to follow the investigational plan, specifically:
- Thirteen of fifty-two subjects did not have a urinalysis at the week 12 study visit
- Twenty seven subjects had the urinalysis analyzed by test strips that had failed the QC process and were not delivering accurate results