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 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection and storage of blood and blood components for were not always followed.
21 CFR 630.10(b). Form and manner of educational material Failure to present educational material to the donor in an appropriate form and in a manner designed to be understood by the donor.
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.
21 CFR 606.160(b). Required records Failure to maintain donor, processing and general records.
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
Lufkin, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.