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FDA establishment 3009093259, Highland, Utah, United States. Part of John Meadors's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: May 7, 2018
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 812.140(e). Notice of transfer of responsibility for records A notice of transfer of responsibility for the maintenance of required records was not submitted.
21 CFR 812.140(a)(3)(i). Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all complete.
21 CFR 812.110(b). Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with the investigational plan and applicable FDA regulations.
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 812.140(a)(2)(i). Investigator device accountability inadequate Records of receipt, use and disposal of a device that relate to the type and quantity, dates of receipt and batch number or code mark of the device are not all complete.
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, condition during the course of the investigation and all diagnostic test results are not all complete.
21 CFR 812.140(a)(3)(iii). Investigator records of exposure to device inadequate Records of each subject's exposure to the device, including the date and time of each use and the use of any other therapy are not all complete.
21 CFR 812.140(a)(3). Investigator's subject records inadequate Records of each subject's case history and exposure to the investigational device are not all complete.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Part of