FDA 483 - American Natl. Red Cross-Greater Chesapeake & Potomac Region - June 23, 2008

The FDA Form 483 details multiple significant deficiencies at the Greater Chesapeake and Potomac Region facility.

**Facility and Operation Details:** The facility is involved in the collection, processing, and distribution of whole blood and blood components, including leukoreduced red blood cells and platelet products.

**Violations and Observations:**

1. **Overweight Whole Blood Units:** The region failed to identify, investigate, correct, and trend 197 instances of overweight whole blood units collected between November 2006 and May 2008. This violates step 3 of a redacted SOP requiring deviation logging, tracking, and trending. This issue was previously cited in April-June 2002 and September-January 2006 FDA inspections, indicating ineffective corrective actions. 2. **Inadequate Manufacturing Record Reviews and Non-Conforming Products:** * **Irradiated RBCs without Second Party Review:** On 12/31/07, 10 leukoreduced red blood cells were distributed on 11/22/07 without required second-party review of the irradiation batch record. The investigation (Exception Report redacted) lacked root cause analysis and a formal Corrective Action Plan (CAP). Consignees were notified eight days after discovery, exceeding the 48-hour requirement of Paragraph X.E of the April 15, 2003 Amended Consent Decree. *