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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
21 CFR 820.70(i). Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of the quality system have not been documented.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
7382.850, Inspection of Medical Device Manufacturers
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
Southlake, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.