FDA Inspection 1000065 — Lerado Zhongshan Peaceful Cove Business Trading CO., LTD
The FDA completed an inspection of Lerado Zhongshan Peaceful Cove Business Trading CO., LTD on Sep 1, 2016 in Zhongshan. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Zhongshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |