FDA 483 - American Red Cross Blood Services - June 15, 2010

The FDA Form 483 details multiple observations from an inspection of a blood collection operation, likely the American Red Cross, concerning deficiencies in their mobile blood drive procedures and quality systems.

**Violations and Observations:**

1. **Inadequate SOPs and Non-Adherence to Procedures:** * Written SOPs for blood collection, specifically American Red Cross Job Aid 15.4J608 and Document 15.3.079, lack specific environmental conditions (e.g., temperature parameters) for mobile site setup. * Blood drives were operated despite noted deficiencies in environmental conditions. * **Temperature Issues:** Multiple instances of blood drives operating in very cold conditions (59-62°F) at Tully Health Center - Stamford (2/27/2010, 3/13/2010) and Philip R. Smith Elementary School (2/8/2010), causing discomfort to staff/volunteers and requiring heat adjustments or site relocation. * **Ventilation Issues:** Staff and donors affected by fumes at Masonicare at Newtown (4/9/2009) and secondhand smoke at Raymond T. Goldbach VFW Post (5/6/2009) and VFW Post 5157 (2/22/2010), with staff needing to leave due to smoke.