FDA Inspection 1337614 — Orthopedic Generations LLC
The FDA completed an inspection of Orthopedic Generations LLC on Sep 25, 2026 in Mokena, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mokena, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |