FDA 483 - American National Red Cross (the) - September 26, 2008

This FDA Form 483 was issued to Kay E. Schwartz, CEO of American Red Cross Blood Services, a regional office located at 825 John Street, West Henrietta, NY 14586. The inspection occurred from July 28, 2008, to September 26, 2008.

The inspection revealed several violations related to the firm's quality system and adherence to written procedures:

**Observation #4:** The firm failed to ensure Quality Assurance (QA) review and approval/rejection of Corrective Action Plans (CAPs) within five business days as required by their written procedure. Two specific instances were cited where CAPs were not QA approved within the five-day timeframe.

**Observation #5:** The firm did not consistently follow its written procedure for submitting Monthly Summary Reports to the Medical Director prior to sending them to BHQ. This was noted for Quality Process Reviews reports for March, April, May, June, and July 2008.

**Observation #6:** The firm failed to accurately answer questions in the Automated Problem Management System (APMS) regarding "which supervisors were involved" and "workload" during problem investigations, as defined by their written procedure. Examples included discrepancies between documented answers and root cause statements for a date of birth resolution issue and a line connection mix-up.

**Observation #7:** The firm's QA-approved Corrective Actions (C