FDA Inspection
Sharp Appliances Ltd.Sharp Appliances Ltd. – FDA Inspection, May 24, 2023
Record Details
This FDA Inspection record concerns Sharp Appliances Ltd., with an inspection on May 24, 2023, issued by the Office of Inspections and Investigations.
- Company
- Sharp Appliances Ltd.
- Inspection Date
- May 24, 2023
- People
- Gregory M. Bessette (Issuing Officer)
- Nassim Ben Makhlouf (Issuing Officer)
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ID · ddc46d51-7d29-41fa-a8c7-fa5cddde9aed
Inspection Facts
- Inspection number
- 1206171
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1030.10(c)(3)(iii)Measurements with tap water container
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Other FDA inspections of Sharp Appliances Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2024 | Not classified | Office of Inspections and Investigations | |
| May 4, 2017 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 20, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 23, 2009 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Sharp Appliances Ltd.
- FDA Inspection 1260673 - 2024-10-28
- FDA Inspection 1019343 - 2017-05-04
- FDA Inspection 734271 - 2011-05-20
- FDA Inspection 584124 - 2009-03-23
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