5. Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall. [21 CFR 606.165(a)]. For example,
(a) A query of your firm’s computer system for expired products which are not in quarantine and not previously shipped, identified seven units of Red Blood Cells, Fresh Frozen Plasma or Platelet pools. Your firm cannot determine if the units have been transfused or distributed since they are electronically still in inventory but cannot be physically located.
(b) Your firm identified instances where a final disposition could not be determined. Your firm calls these “discrepant discard” for tracking purposes, though the term “discard” is only used for the electronic discard and there is no evidence that the product was physically discarded...
(c) During our inspection, a Red Blood Cell component was identified as being in quarantine according to an electronic inventory inquiry on January 30, 2013. However, the component could not be located in the expected physical quarantine location. After the discrepancy was identified by our investigators, a search was initiated and the component was found in the discard bin. The component had been physically discarded without maintaining a record of the discard as required by TS 500-2, Final Disposition of Blood Components.
Enfin cette Warning Letter pointe des défaillances dans la maîtrise du changement et la validation des systèmes informatisés :
6. Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)]. For example,
(a) On June 3, 2012, you identified that donor and patient identification numbers are carried forward from previous override functions when an override is performed by the same user. This causes the patient and donor numbers to be replaced with incorrect identification numbers on laboratory override reports. On June 8, 2012, this issue was reported to the computer software manufacturer, however, you failed to implement the computer system workaround identified by them. For example, on January 6, 8, and 10, 2013, at least three units were missing the Patient number and Order number from the PSBC Transfusion Service Laboratory Override Report.
(b) ORF-000055354 documents a problem where demographic changes, including blood type, CMV status and name changes can be lost if a different user is updating the record in another session. On September 4, 2012, this issue was reported to the computer software manufacturer, however, you failed to implement the computer system workaround that the manufacturer identified. During the inspection, your software was tested by BCS staff who confirmed that this event continues to occur when demographic changes are made by different users.