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 812.150(a)(4). Investigator non-emergency safety or soundness changes In a non-emergency situation, the investigational plan that could have affected were initiated without prior approval of the changes from.
21 CFR 812.140(a)(1). Investigator correspondence records inadequate Records relating to correspondence with an IRB, including required reports, are not all accurate.
21 CFR 812.140(a)(4). Investigator record of protocol deviations inadequate Records showing dates each deviation from the protocol are not all complete and current.
21 CFR 812.110(d). Inadequate financial disclosure by investigator The sponsor was not supplied sufficient financial information to allow submission of complete and accurate certification or disclosure statements.
21 CFR 812.110(b). Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
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
Waterloo, Iowa, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.