FDA Inspection 1087414 — ZYTO Technologies, Inc.
The FDA completed an inspection of ZYTO Technologies, Inc. on April 24, 2019 in Pleasant Grove, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pleasant Grove, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |