FDA Inspection 836130 — St. Shine Optical Co., Ltd.
The FDA completed an inspection of St. Shine Optical Co., Ltd. on May 23, 2013 in Tai Bei Shi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tai Bei Shi (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 538 | 21 CFR 820.70(a) | Process control procedures |