FDA Inspection 1270615 — Operating Room Innovations, Inc
The FDA completed an inspection of Operating Room Innovations, Inc on May 22, 2025 in La Jolla, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 22, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- La Jolla, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |