FDA Inspection 851991 — JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD
The FDA completed an inspection of JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD on Sep 5, 2013 in Suzhou. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |