FDA Inspection 1097585 — Vitalconnect Inc.
The FDA completed an inspection of Vitalconnect Inc. on July 25, 2019 in San Jose, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |