QC records lacking for blood bank, letter states.

During an FDA inspection of the Washington Hospital Center's, Washington, D.C., blood bank between July 23 and Aug. 16 FDA documented numerous deviations from applicable current GMP regulations for blood and blood components.

The company failed to maintain records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components so that all steps can be clearly traced, according to the Sept. 19 letter.

For example, the blood bank lacked blood processing records, including results and interpretations of all tests and retests, for donors who were reactive by screening tests for evidence of infection due to a communicable disease agent.

The blood bank also lacked quality control records to document the capacity of a shipping container to maintain proper temperatures while in transit. Specifically, FDA observed that donor blood specimens for nucleic amplification testing had been transported from a mobile collection site to the blood bank laboratory in an unqualified cooler with no thermometer present to ensure that the internal temperature was in the range specified by SOP.

The inspection also revealed the company did not perform a thorough investigation of each reported adverse reaction regarding each unit of blood or blood product arising as a result of blood transfusion.

Specifically, a suspected transfusion-related lung injury (TRALI) reaction was reported to the blood bank on May 25, 2007. The recipient had been transfused with 14 blood components, seven of which were provided to the blood bank by a supplier. FDA observed the blood bank erroneously notified the supplier of only six of the seven involved components, resulting in no TRALI reaction investigation for the seventh component.

There was a failure to maintain and/or follow written SOPs that include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes.

For instance, the letter stated: "The quality assurance unit was required to review Post Donation/Third Party Information Reports (PDRs)." FDA observed QA did not review five PDRs pertaining to information received on Jan. 16, (two donors), Mar. 8, Mar. 30, and Apr. 23, to ensure appropriate disposition of affected blood or blood components until June 13; and a PDR pertaining to information received on June 4, lacked documentation regarding disposition of the affected blood and was not reviewed by QA.

FDA noted the firm did not perform a thorough investigation and make a record of the conclusions and follow-up of any unexplained discrepancy. Specifically, the FDA's review of Process/Product Deviation Reports (PPDR) for the period July 2006 through July 2007 found six PPDRs required follow-up actions; however, there were no records of the follow-up actions.

FDA acknowledged receipt of a company response and found the corrective actions, in general, to be isolated to the inspection and it did not address the underlying causes of the deviations. The response did not provide assurance to the agency that it had taken effective measures necessary to prevent recurrence of the deviations. 14250W