FDA Inspection 1050399 — Sharp U.K. Manufacturing (SUKM)
The FDA completed an inspection of Sharp U.K. Manufacturing (SUKM) on April 23, 2018 in Wrexham. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Wrexham (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5123 | 21 CFR 1030.10(c)(3)(iv) | Door position |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |