FDA Inspection
Western/Scott Fetzer CompanyWestern/Scott Fetzer Company – FDA Inspection, Aug 12, 2016
Record Details
This FDA Inspection record concerns Western/Scott Fetzer Company, with an inspection on August 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Western/Scott Fetzer Company
- Inspection Date
- August 12, 2016
- Product Type
- Devices
View Company Profile
ID · f4b10513-0793-4c8f-8bc7-6d2d638cbcaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981670
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Western/Scott Fetzer Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2018 | Not classified | Cincinnati District Office | |
| September 2, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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