FDA 483 - American National Red Cross - Johnstown, PA - September 16, 2008

The FDA Form 483 details observations from an inspection of the Greater Alleghenies Region (Region) between January 1 and August 31, 2008.

**Violations and Observations:**

1. **Failure to thoroughly review batch failures:** The Region failed to prevent the manufacture, distribution, and transfusion of three units of Packed Red Blood Cells (PRBC) derived from overweight Whole Blood units. Specifically, three redacted Whole Blood units collected on August 25, 2008, January 28, 2008, and January 24, 2008, respectively, were classified as overweight but subsequently manufactured, shipped, and transfused.

2. **Failure to perform thorough investigation of unexplained discrepancies:** * The Region collected 78 overweight Whole Blood units between January 1 and August 31, 2008. While three PRBC units from these were identified as problems and logged into the Automated Problem Management System (APMS) on September 5, 2008, no investigation was initiated for the remaining 75 overweight units as of September 16, 2008, nor were they logged into the APMS. This violates Paragraph IV.B.1 of the April 15, 2003, Consent Decree of Permanent Injunction (Decree). * A Red Blood Cells Pher