FDA Inspection 1099964 — Wisdom Medical Technologies
The FDA completed an inspection of Wisdom Medical Technologies on August 19, 2019 in Dalton Gardens, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dalton Gardens, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |