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FDA establishment 3007184242, Duluth, Georgia, United States. Part of Kennedy, Philip R.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 2
Last inspection ended: Oct 16, 2019
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 812.150(b)(5). Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted at required intervals and at least yearly to FDA and all reviewing IRBs.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured and IRB review and approval were not ensured.
21 CFR 812.140(a)(2)(i). Investigator device accountability inadequate Records of receipt and use 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 accurate, complete and current.
21 CFR 812.140(d). Record retention inadequate Required records were not all maintained during the investigation and for a period of two years after the date on which an investigation was terminated or completed.
21 CFR 812.110(b). Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with the investigational plan, applicable FDA regulations, conditions of approval imposed by an IRB and conditions of approval imposed by FDA.
21 CFR 812.150(b)(6). Sponsor notif. of rqst. to return/repair/dispose not made Notification was not sent to FDA and all reviewing IRBs of a request that an investigator repair and dispose of any units of a device.
21 CFR 812.25(e). Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.
21 CFR 812.150(b)(1). Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted within 10 working days of receiving notice of the effect to FDA and all reviewing IRBs.
21 CFR 812.43(c)(5). No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement.
Official Action Indicated (OAI)
May 29, 2009
Devices · Bioresearch Monitoring
11 cited references
21 CFR 812.25(e). Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.
21 CFR 50.25(a)(1). Procedures, identification of those which were experimental The informed consent document did not contain identification of any procedures which were experimental.
21 CFR 812.150(b)(1). Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted within 10 working days of receiving notice of the effect to FDA and all reviewing IRBs.
21 CFR 812.150(b)(5). Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted at required intervals and at least yearly to all reviewing IRBs.
21 CFR 812.42. Sponsor began study before IRB/FDA approval Part of an investigation was initiated before FDA approval and IRB approval.
21 CFR 812.43(d). Monitors not qualified Monitors that are qualified by training and experience were not chosen to monitor the investigational study.
21 CFR 812.43(c)(5). No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured.
21 CFR 50.20. Consent not obtained, exceptions do not apply Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
21 CFR 812.150(b)(6). Sponsor notif. of rqst. to return/repair/dispose not timely Notification to FDA and all reviewing IRBs of a request that an investigator return and repair any units of a device was not made within 30 working days after the request and did not state why the request was made.
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 accurate, complete, and current.
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
Duluth, Georgia, United States. Part of