21 CFR 606.100(b). SOPs for investigations, records Written standard operating procedures for all steps in the investigation of product deviations under the regulations were not established, maintained and followed.
21 CFR 606.160(b). Required records Failure to maintain storage and distribution, quality control and general records.
21 CFR 630.40(c). Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor was deferred or determined not to be eligible for donation.
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced.
Voluntary Action Indicated (VAI)
May 29, 2019
Biologics · Blood and Blood Products
5 cited references
21 CFR 606.160(a)(1). Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the processing of each unit of blood and blood components so that all steps can be clearly traced.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation and make a record of the conclusions and follow-up of a failure of a lot or unit to meet any of its specifications.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.160(b). Required records Failure to maintain processing, quality control and general records.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the distribution of blood and blood components for allogeneic transfusion were not always followed.
Voluntary Action Indicated (VAI)
May 4, 2017
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Jan 15, 2015
Biologics · Blood and Blood Products
4 cited references
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection and processing of blood and blood components for homologous transfusion and autologous transfusion are not always maintained.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
21 CFR 606.160(a)(1). Legibility and indelibility Records are illegible and not indelible.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to identify the person performing the work so as to provide a complete history of the work performed.
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