FDA 483 - American National Red Cross, The - September 15, 2010

The FDA Form 483 details observations from an inspection, highlighting deficiencies in investigation and review processes for donor incidents and adverse reactions.

A critical finding involves Case ID# C20100615556op, where a donor sustained an injury from a contaminated needle stick during venipuncture. The phlebotomist reported poking her finger with the needle, noting blood, then using the unsterile needle on the donor. This incident was not logged, investigated, or corrective action entered into the automated problem-management system (APMS) as required. The medical director was not notified until over a month later (07/20/10), and the donor was temporarily deferred on 07/23/10.

Furthermore, the inspection revealed a failure to conduct thorough investigations of reported adverse reactions. Specifically, Medical Director reviews of Donor Reaction and Injury Records (DRIR) were not consistently performed within a reasonable timeframe, violating written procedure Doc No 15.3.055, Version 1.1. Of 13 DRIRs reviewed between October 2009 and June 2010, 10 were not reviewed timely by the Medical Director and/or Final Quality Review. Four of these also lacked a Final Quality Review. Examples include delays of approximately 6 months for Case ID# C20091101646op, 6 weeks for C20