FDA Inspection 987363 — XZeal Technologies, Inc.
The FDA completed an inspection of XZeal Technologies, Inc. on October 5, 2016 in Kissimmee, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 5, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kissimmee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |