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FDA establishment 3003857817, Maple Grove, Minnesota, United States. Part of Dane Technologies's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 0
Last inspection ended: Aug 25, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities have not been adequately established.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
Voluntary Action Indicated (VAI)
Mar 18, 2022
Devices · Compliance: Devices
3 cited references
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities have not been adequately established.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
Voluntary Action Indicated (VAI)
Oct 17, 2012
Devices · Compliance: Devices
5 cited references
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.200(d). Service reports Service reports are not documented.
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 adequately established.
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
Maple Grove, Minnesota, United States. Part of