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 606.60(b). Equipment calibration frequency Equipment used in the collection of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, compatibility testing, storage, and distribution of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 606.160(a)(1). Legibility and indelibility Records are not indelible.
21 CFR 606.100(c). Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
21 CFR 606.121(c)(8). Caution statement - transfusion The product is intended for transfusion and the container label fails to include the statement(s) ?Rx only?.
21 CFR 606.160(b)(6). Required records - transfusion reaction and complaints Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up.
21 CFR 606.171. Biological product deviation report Failure to submit a biological product deviation report.
21 CFR 606.100(c). Thorough investigations Failure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy and a failure of a lot or unit to meet any of its specifications.
21 CFR 606.60(a). Equipment observed, standardized, calibrated Equipment used in the compatibility testing of blood and blood components is not calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
21 CFR 640.3(a). Donor suitability not performed on day of collection Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection.
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
Galax, Virginia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.