FDA 483 - American National Red Cross (The) - April 23, 2010

On April 5-23, 2010, an FDA inspection was conducted at the American National Red Cross facility located at 4860 Sheboygan Avenue, Madison, WI 53705. The inspection was issued to Gregory L. Novinska, Chief Executive Officer.

The inspection revealed one observation: Written standard operating procedures (SOPs) for blood and blood component collection for homologous transfusion were not always followed.

Specifically: 1. **Work Instruction 15.3.51, Determining the Need for Risk Management Notification:** Three cases (04/22/2009, 06/30/2009, 10/05/2009) where donors sought medical treatment after donating were not documented as reported to Risk Management on the Donor Reaction and Injury Record (DRIR). The 10/05/2009 DRIR also lacked Medical Director Signature and Final Quality Review. 2. **Work Instruction 15.3.55, Performing Final Case and Donor Suitability Assessment:** Four DRIRs (01/10/2009, 10/05/2009, 10/26/2009, 11/25/2009) were missing the Medical Director Review, Recommendation, Signature, and Final Quality Review