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21 CFR 606.151(e). Procedures to maintain records of emergency transfusions Records including signature by the physician requesting the procedure are not maintained of all emergency transfusions.
Voluntary Action Indicated (VAI)
Aug 18, 2022
Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
May 18, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jan 13, 2017
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Jan 29, 2015
Biologics · Blood and Blood Products
2 cited references
21 CFR 606.100(c). Thorough investigations Failure to 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.
Voluntary Action Indicated (VAI)
Dec 26, 2012
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Dec 22, 2010
Biologics · Blood and Blood Products
3 cited references
21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
21 CFR 610.47. Notification of transfusion recipients Failure to notify the attending physician of a recipient of a lookback unit.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation of a failure of a lot or unit to meet any of its specifications.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports