Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
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 211.100(a). Approval and review of procedures Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
21 CFR 606.151(e). Procedures to maintain records of emergency transfusions Records are not maintained of all emergency transfusions including complete documentation justifying the emergency action.
Voluntary Action Indicated (VAI)
Feb 21, 2017
Biologics · Blood and Blood Products
3 cited references
21 CFR 606.160(b). Required records Failure to maintain general records.
21 CFR 600.10(b). Personnel capabilities Failure to assure that personnel have the necessary training in and a thorough understanding of the operations which they perform.
21 CFR 600.14(c). When to report Biological product deviations were not reported within the 45 calendar day timeframe.
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
Chicago, Illinois, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.