FDA Inspection 714471 — SteriGear, LLC
The FDA completed an inspection of SteriGear, LLC on March 17, 2011 in Pleasant Grove, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pleasant Grove, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |