1171453
Xintec Corp — FEI 2938889
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 7, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |