FDA Inspection 1310976 — Oak Ridge Products, LLC
The FDA completed an inspection of Oak Ridge Products, LLC on April 1, 2026 in Mchenry, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mchenry, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23135 | ISO 13485:2016 Clause 7.3.9 | Records of design and development changes and their reviews not maintained |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |