FDA Inspection 913333 — Jingzhou Haixin Green Cross Medical Products Co. Ltd.
The FDA completed an inspection of Jingzhou Haixin Green Cross Medical Products Co. Ltd. on Dec 11, 2014 in Jingzhou. 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
- Dec 11, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Jingzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |