FDA Inspection 1019343 — Sharp Appliances Ltd.
The FDA completed an inspection of Sharp Appliances Ltd. on May 4, 2017 in Bangpakong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bangpakong (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5116 | 21 CFR 1030.10(c)(2)(v) | Secondary safety interlock failure |