FDA Inspection 989627 — Xintec Corp
The FDA completed an inspection of Xintec Corp on Sep 13, 2016 in Alameda, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 13, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |