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FDA establishment 1000118628, Denton, Texas, United States. Part of Five Star Orthodontic Lab & Supply's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Mar 17, 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 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable suppliers have not been adequately established.
21 CFR 820.198(a). Complaints Complaint files are not adequately maintained.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been established.
21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 806.20(a). Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.
21 CFR 820.180. Availability Required records were not made readily available for review and copying by the FDA.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately 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.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established and maintained.
21 CFR 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable suppliers, contractors and consultants 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
Denton, Texas, United States. Part of