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 812.140(a)(3)(ii). Investigator records of relevant observations inadequate Records for each subject concerning previous medical history, condition upon entering the investigation and condition during the course of the investigation are not all complete.
21 CFR 812.110(a). Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining IRB and FDA approval to conduct the investigation.
21 CFR 812.100. Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the investigational plan.
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
Highland, Utah, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.