FDA did not post any new warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary from Striverdi Respimat (olodaterol hydrochloride) submitted by Boehringer Ingelheim). Four sites were selected for inspection based on enrollment. Site inspections lasted 3 to 11 days and the sponsor inspection took place over 7 days. One investigator received a FDA Form 483.
Dr. de Salvo was cited for failing to maintain adequate and accurate records and inadequate records of final drug disposition:
- Providing investigational product kits that were not what the IXRS for the trial assigned to seven subjects.
- The study monitor could not locate returned drug from six subjects
FDA notes that a sensitivity analysis of the study data was conducted excluding the study site data as a result of the observations.