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FDA establishment 3002706372, Charlotte, North Carolina, United States. Part of Drake Precision Dental Laboratory's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Nov 5, 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 820.198(b). Rationale documented for no investigation Records for complaints where no investigation was made do not include required information.
21 CFR 820.198(d). Evaluation, timeliness, identification Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations have not been documented.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
21 CFR 820.75(b)(2). Documentation of validated process performance There is no documentation of monitoring and control methods and data and the major equipment used for a validated process.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been established.
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 820.75(a). Documentation Process validation activities and results have not been documented.
21 CFR 820.40(a). Document review, approval by designated individual Documents were not reviewed and not approved by designated individual(s) prior to issuance .
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations and checks have not been documented.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been 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. 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 and warning letters
Charlotte, North Carolina, United States. Part of