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 600.11(a). Work areas The manufacturing areas are not kept clean, orderly and free from dust, dirt, vermin and other objects not required for manufacturing.
21 CFR 606.40(a)(1). Provide space for examination Failure to provide adequate space for private examinations of individuals to determine their eligibility as blood donors.
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.
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
Fort Worth, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.