FDA Inspection 1101097 — Ultra Solutions Manufacturing LLC.
The FDA completed an inspection of Ultra Solutions Manufacturing LLC. on August 29, 2019 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |