FDA Inspection 1311204 — Fudakang Industrial Co Ltd
The FDA completed an inspection of Fudakang Industrial Co Ltd on March 12, 2026 in Dongguan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dongguan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |