DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
|DATE||June 22, 2009|
|FROM||Janet White, Bioresearch Monitoring Branch, HFM-664|
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
|THROUGH||Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664|
|TO||Salim Haddad, Chair, NDA Committee, HFM-335|
|SUBJECT||Bioresearch Monitoring Inspection Results|
Sponsor: Fenwal, Inc.
Product: Platelet Additive Solution III (PAS III) – InterSol Solution
The bioresearch monitoring inspections of three clinical sites did not reveal problems that impact the data submitted in the application.
This study was conducted at three clinical sites and inspections of all three clinical investigators were performed in support of this New Drug Application (NDA). The inspections focused on specific questions concerning one study protocol with two amendments and the comparison of information from the NDA to source documents.
|The American National Red Cross - Penn Jersey Region||01||Philadelphia,|
| Amendment 1: 29|
Amendment 2: 14
Blood Center of Wisconsin
|Amendment 1: 39|
Amendment 2: 14
|Yale-New Haven Hospital||03||New Haven,|
|Amendment 1: 33|
Amendment 2: 22
|STUDY TITLE:||Amendment 1: Evaluation of PAS III (InterSol Solution) for the Storage of Platelets Up to -(b)(4)-Days|
Amendment 2: Evaluation of PAS III (InterSol Solution) for the Storage of Platelets Up to Five Days Including In Vivo Study and Gamma Irradiation
Site 01: At this site, there was documentation showing three protocol deviations for Protocol FCRP-0106, Amendment #1, but these deviations were not included in the submission to the FDA by the sponsor.
Site 02: No sponsor or monitoring issues were noted at this site.
NOTEWORTHY INSPECTIONAL FINDINGS
The inspections at Site 01 and Site 02 revealed no deviations from applicable regulations.
Site 03: There were only a few minor problems noted. Ten of 33 subjects participating in the study were not consented properly. Eight subjects were given the incorrect version of the informed consent document, and two subjects were given a revised version that lacked the additional risk information included in the previous version. Also, the lot number of Platelet Additive Solution III was not recorded at the time of use as required by amendment 1 of the protocol.
BIMO ADMINISTRATIVE FOLLOW-UP
Inspection closeout letters were issued to the clinical investigators at all three of the study sites. Please contact me at (301) 827-6336 if you have any questions about this memo or any aspect of bioresearch monitoring.
Consumer Safety Officer