FDA 483 - American Red Cross Blood Svs. Indiana-Ohio Region - July 21, 2010

This FDA Form 483 document details observations from an inspection, citing a failure to follow the Amended Consent Decree of Permanent Injunction #93-0949 dated April 15, 2003, Paragraph IV.B.1 (c) and (d). The facility, specifically the Donor Client Services Center (DCSC) in Charlotte, failed to implement and monitor detailed corrective action plans.

Corrective Actions #1 and #2 for Issue I-00911916-FC, concerning the reconciliation of test results, did not adequately address identified root causes, nor did they specify timeframes for effectiveness checks (ECs) or actions for when ECs fail. These corrective actions were also not completed within designated timeframes.

A critical finding involved Exception report # E-0718847 (April 6, 2010), where DCSC Charlotte failed to enter Anti-HTLV reactive confirmatory test results by January 8, 2010, and consequently failed to submit a donor to the National Donor Deferral Registry (NDDR) by February 8, 2010. This delayed donor notification and the Lock Back process, which depend on reconciled confirmatory test results.

The Root Cause Investigation (closed May 11, 2010) identified probable causes: no defined process for test result distribution and accounting by Charlotte DCSC teams, no defined