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)(9). Written methods for investigating adverse reactions The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient reactions.
21 CFR 606.160(a)(1). Person performing, test results, interpretation Records fail to show test results so as to provide a complete history of the work performed.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection of blood and blood components for further manufacturing purposes were not always followed.
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
Surprise, Arizona, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.