Company: American Blood Resources Association
Date: 7/31/01
Product: Blood Bank Deferral Software
During an inspection of your facility located in Annapolis, Maryland, on June 18 through 22, 2001, Food and Drug Administration (FDA) investigators determined that you manufacture and distribute, Blood Bank Deferral Software. This software is a device within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The device is considered adulterated within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or controls used in the manufacture, processing, packaging, storage, or distribution of this software are not in conformance with the Quality System Regulation for Medical Devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
Failure to document and validate design changes in that the National Donor Deferral Registry (NDDR) software was changed with regard to year 2000 update, modification of program files _____ and _____, without documenting the design changes, testing, validation, and verification as required by standard operating procedures (SOPs)(21 CFR 820.30(i)).
Failure to maintain a complete Device Master Record (DMR). For example, the DMR lacked complete specifications for software installed on the host server and deferral record activity codes (21 CFR 820.181).
Failure to establish and maintain adequate document change controls in that the business practice was changed regarding the use of computer generated _____ as opposed to the use of _____ numbers, for donor identification. The NDDR user manuals and design specifications were not changed to reflect this new practice. Also, approval of standard operating procedures was not documented in that the procedures lacked signatures of the individuals approving the documents and/or dates of approval. For example, SOP 33.003, “User Record Maintenance” and SOP 33.004, “Monthly Activity Report,” were not signed as being approved (21 CFR 820.40(b)).
Failure to conduct and document quality audits to assure the quality system is in compliance with quality system requirements (21 CFR 820.22) and to document the evaluation of contractors (21 CFR 820.50(a)). For example, there was no documentation available to show that either internal quality audits or an evaluation of the contract software developer had ever been performed.
FDA District: Baltimore
