Oregon Health & Science University – FDA Warning Letter, May 12, 2010

The FDA conducted inspections of Oregon Health & Science University's Special Immunology and Coagulation Laboratory (SIC) from April 20-28, 2010, and Pacific Northwest Transplant Bank (PNTB) from April 28-May 12, 2010. The SIC laboratory was found to have significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

A primary violation was the failure to use appropriate FDA-licensed, approved, or cleared donor screening tests in accordance with manufacturer's instructions [21 CFR 1271.80(c)]. Specifically, between August 3 and September 3, 2008, SIC used an expired Hepatitis B Virus Core Antigen EIA screening test (expired July 29, 2008) for six HCT/P donors. Between February 9 and February 24, 2010, SIC used an expired Hepatitis C Virus Encoded Antigen EIA screening test (expired January 12, 2010) for five HCT/P donors. PNTB confirmed that results from these expired tests were used for donor eligibility determinations, and HCT/Ps from these donors were distributed.

The FDA acknowledged a May 6, 2010, response from OHSU, but deemed it inadequate.