FDA Inspection 1271550 — Hong Qiangxing (Shen Zhen) Electronics Limited
The FDA completed an inspection of Hong Qiangxing (Shen Zhen) Electronics Limited on August 7, 2025 in Baoan District. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
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 |