1271550
Hong Qiangxing (Shen Zhen) Electronics Limited — FEI 3010402752
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 7, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baoan District (China)
Citations
| ID | CFR | Description |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |