FDA Inspection 896116 — XZeal Technologies, Inc.
The FDA completed an inspection of XZeal Technologies, Inc. on September 18, 2014 in Kissimmee, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kissimmee, FL (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 |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |