FDA Inspection
Hamilton Thorne, IncHamilton Thorne, Inc – FDA Inspection, Jan 10, 2013
Record Details
This FDA Inspection record concerns Hamilton Thorne, Inc, with an inspection on January 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hamilton Thorne, Inc
- Inspection Date
- January 10, 2013
- Product Type
- Devices
View Company Profile
ID · f90e7e9c-bbfb-43aa-9a42-b4987aeb93d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814255
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Hamilton Thorne, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 9, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| August 3, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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