FDA Inspection 954643 — A&E NICE MACHINERY INDUSTRY CO., LTD. NAN YI SHYTH CO., LTD
The FDA completed an inspection of A&E NICE MACHINERY INDUSTRY CO., LTD. NAN YI SHYTH CO., LTD on Nov 5, 2015 in Zhongshan City. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zhongshan City (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |