FDA Inspection 644532 — Ultroid Technologies, Inc.
The FDA completed an inspection of Ultroid Technologies, Inc. on February 9, 2010 in Tampa, FL. 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
- February 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2330 | 21 CFR 820.22 | Quality audit corrective action, reaudits {see also 820.100} |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate 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 |
| 3159 | 21 CFR 820.184 | DHR content |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3374 | 21 CFR 820.198(d)(3) | Determination of relationship of device to event |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4189 | 21 CFR 820.198(a) | General |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |