FDA Inspection 782021 — Galloway Technologies, LLC
The FDA completed an inspection of Galloway Technologies, LLC on May 17, 2012 in Saratoga Springs, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saratoga Springs, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3837 | 21 CFR 820.25(b) | Training records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |