FDA Inspection
Sharp U.K. Manufacturing (SUKM)Sharp U.K. Manufacturing (SUKM) – FDA Inspection, May 3, 2016
Record Details
This FDA Inspection record concerns Sharp U.K. Manufacturing (SUKM), with an inspection on May 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 3, 2016
- Product Type
- Devices
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ID · 02a42c78-515f-4a8c-9a84-4844e32a9e4d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 970679
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 1030.10(c)(3)(iii)Measurements with tap water container
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
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Other FDA inspections of Sharp U.K. Manufacturing (SUKM)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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