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FDA establishment 3015194291, University Park, Illinois, United States. Part of United Dental Resources Corporation's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Aug 7, 2026
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.
ISO 13485:2016 Clause 7.1: Records of risk management activities in product realization not maintained1
Inspections
1 inspections, newest first
Ended
Product and area
Citations
Classification
Aug 7, 2026
Devices · Compliance: Devices
3 cited references
21 CFR 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
21 CFR 820.35(a). Records of complaint investigations do not include required information Records of complaint investigations do not include the name of the device, any unique device identifier (UDI) or universal product code (UPC) and any other device identification(s), the name, address, and phone number of the complainant and any reply to the complainant.
ISO 13485:2016 Clause 7.1. Records of risk management activities in product realization not maintained Records of risk management activities in product realization were not 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
University Park, Illinois, United States. Part of