FDA Inspection 970679 — Sharp U.K. Manufacturing (SUKM)
The FDA completed an inspection of Sharp U.K. Manufacturing (SUKM) on May 3, 2016 in Wrexham. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 3, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Wrexham (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 5122 | 21 CFR 1030.10(c)(3)(iii) | Measurements with tap water container |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |