FDA Inspection 1158487 — Vivalnk, Inc.
The FDA completed an inspection of Vivalnk, Inc. on Dec 10, 2021 in Campbell, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Campbell, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |