FDA Inspection 1243634 — Taizhou Honod Medical Co. Ltd.
The FDA completed an inspection of Taizhou Honod Medical Co. Ltd. on Jun 20, 2024 in Taizhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 20, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Taizhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |