We were just inspected by the FDA in January. We did report to the FDA when a product wasn't issued in the computer, and she agreed that we should. The reason being, at the time of issue, we document in the computer that the visual inspection at that time is "ok". By forgetting to issue it in the computer, we were not documenting the final visual inspection when the unit left the blood bank, so it was reportable. This occured only on units we had to deliver to the OR or the ER. We would just pull part of the unit tag and document where the unit went, date, time and who delivered. Now we add "ok" for visual inspection.