FDA Inspection 727344 — Changchun New Industries Optoelectronics Tech. Co., Ltd.
The FDA completed an inspection of Changchun New Industries Optoelectronics Tech. Co., Ltd. on May 23, 2011 in Changchun. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Changchun (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 5029 | 21 CFR 1005.25(a) | Failure to designate US agent for process service |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5158 | 21 CFR 1040.10(f)(6)(i) | Beam attenuator |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |