FDA Inspection 1155227 — XCATH INC
The FDA completed an inspection of XCATH INC on Oct 26, 2021 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 26, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |