FDA 483 - The American National Red Cross - September 27, 2010

This FDA Form 483 details significant deviations from standard operating procedures (SOPs) in the collection, processing, storage, and distribution of blood and blood components.

**Observation 1** highlights widespread non-compliance with written SOPs. * **Donor Reaction and Injury Reports:** 22 donor complication cases lacked final quality review, and 7 cases had reviews delayed by 3-6 months or more. Eight severe donor reaction/injury cases, including instances requiring emergency transport or medical treatment (e.g., donor passing out, seeking ER treatment for pain, hospital admission, head injury), were not reported to the risk management officer as required. * **BacT Alert Record Management:** 9 of 16 Component Status Change Records (CSCRs) were incomplete or missing sections. Process verification was not documented, was incorrectly documented, or was significantly delayed (over 3 months) in 12 of 16 CSCR cases. Donor Status Change Records (DSCRs) were not followed or were incorrectly verified in at least 13 of 16 files, with 10 of 16 DSCRs lacking verification or being verified over 3 months late. 12 of 16 Positive Bacterial Culture Case Files lacked operational review or had delayed reviews. * **Emergency/Exceptional Releases:** The SEM Region lacked a written appointment for a regional coordinator for exceptional and emergency releases. A designee reviewed