FDA 483 - American National Red Cross - Johnstown, PA - September 24, 2010

The FDA inspected the American Red Cross Greater Alleghenies Region, a blood bank in Johnstown, PA, from September 7-24, 2010. The inspection revealed five observations.

Observation 1 noted that thorough investigations of reported adverse donor reactions were not always completed, not completed within a reasonable time, or not within the three-month limit specified by internal documents. Several examples were provided, including a donor hospitalized for three days whose Donor Reaction and Injury Record (DRIR) was not reviewed for six months, and other DRIRs that lacked final quality review as of September 17, 2010, with one donor making subsequent donations before their adverse reaction investigation concluded.

Observation 2 stated that personnel responsible for blood collection lacked adequate training and experience. Specifically, the facility failed to create and implement training for the use of hand warmers on donors' hands prior to finger sticks for hemoglobin analysis.

Observation 3 indicated that written standard operating procedures for blood collection were not always maintained and followed. An example cited was an unopened package of collection bags (lot FM10F10020) stored separately from other actively used bags during a mobile drive.

Observation 4 found that written procedures were not always reviewed and approved by the quality control unit annually, contrary to the firm's own procedure (document 03.3.003, version 2.1). Examples included procedures approved in 20