FDA Inspection
Sharp Appliances Ltd.Sharp Appliances Ltd. – FDA Inspection, May 4, 2017
Record Details
This FDA Inspection record concerns Sharp Appliances Ltd., with an inspection on May 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Gregory M. Bessette (Issuing Officer)
- Michael P. Sweeney (Issuing Officer)
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ID · ed95e0aa-32ca-48b3-94ed-7cbd04b6fdbf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019343
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(2)(v)Secondary safety interlock failure
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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 24, 2023 | Not classified | Office of Inspections and Investigations | |
| 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 1206171 - 2023-05-24
- FDA Inspection 734271 - 2011-05-20
- FDA Inspection 584124 - 2009-03-23
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