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FDA establishment 3002716534, Charlotte, North Carolina, United States. Part of Compumedics USA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Sep 16, 2021
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 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.20(c). Management review dates The results and/or dates of management reviews are not documented.
21 CFR 820.170(b). Installer records The person installing the device did not adequately document the inspection and test results to demonstrate proper installation.
21 CFR 820.50(a)(2). Supplier oversight The type and extent of control to be exercised over the product and services was not clearly defined.
21 CFR 820.200(d). Service reports Service reports do not include the required information.
21 CFR 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.198(b). Review and evaluation for investigation Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
21 CFR 820.40(b). Document change records, maintained. Records of changes to documents were not maintained.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
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(b). Analyzing service report Service reports were not analyzed following appropriate statistical methods.
21 CFR 820.170(a). Lack of or inadequate instructions inspection instructions and test procedures have not been established.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations, inspections and maintenance activities have not been documented.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for verifying that servicing meets specified requirements have not been adequately established.
No Action Indicated (NAI)
Apr 13, 2018
Devices · Compliance: Devices
4 cited references
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 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.198(e). Records of complaint investigation Records of complaint investigations do not include required information.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
Voluntary Action Indicated (VAI)
May 7, 2015
Devices · Compliance: Devices
4 cited references
21 CFR 820.170(b). Installer records The person installing the device did not document the inspection and test results to demonstrate proper installation.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.86. Acceptance status The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria and maintained.
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
Charlotte, North Carolina, United States. Part of