Puget Sound Blood Center and Program

Puget Sound Blood Center and Program
Product: blood and blood products
Date: 3/16/2013

During the inspection, FDA investigators documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (21 CFR), Parts 606, 610 and 640 and the cGMP regulations for finished pharmaceuticals, 21 CFR Part 211. These deviations cause your blood products to be adulterated within the meaning of Section 501(a)(2)(B) of the Food, Drug and Cosmetic Act (the Act). [21 U.S.C. 351(a)(2)(B)]. These deviations include but are not limited to the following:

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<.p>

FDA District Office: Seattle District

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