FDA Inspection 878262 — SteriGear, LLC
The FDA completed an inspection of SteriGear, LLC on May 9, 2014 in Pleasant Grove, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pleasant Grove, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |