FDA Inspection
Oak Ridge ProductsOak Ridge Products – FDA Inspection, Sep 30, 2022
Record Details
This FDA Inspection record concerns Oak Ridge Products, with an inspection on September 30, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oak Ridge Products
- Inspection Date
- September 30, 2022
- Product Type
- Devices
View Company Profile
ID · 65a5c1d6-8d2f-47f2-8abd-052dafefd15a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180761
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oak Ridge Products
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2026 | NAI | Chicago District Office | Postmarket Assurance: Medical Devices |
| October 26, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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