FDA Inspection 1053875 — Ushio America, Inc.
The FDA completed an inspection of Ushio America, Inc. on May 31, 2018 in Vergennes, VT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 31, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Vergennes, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3696 | 21 CFR 820.100(b) | Documentation |