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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)
Jan 28, 2014
Biologics · Blood and Blood Products
None posted
No Action Indicated (NAI)
Apr 21, 2010
Biologics · Blood and Blood Products
5 cited references
21 CFR 606.65(e). Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.
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 further manufacturing purposes are not always maintained and followed.
21 CFR 606.160(b). Required records Failure to maintain general records.
21 CFR 630.40(a). Supplemental results Failure to notify a donor of the results of supplemental testing.
21 CFR 630.40(a). Notification Failure to make reasonable attempts to notify a donor who has been deferred based on the results of tests for evidence of communicable disease agent(s).
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. 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 and warning letters
Reseda, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.