FDA Inspection
Western/Scott Fetzer CompanyWestern/Scott Fetzer Company – FDA Inspection, Aug 29, 2018
Record Details
This FDA Inspection record concerns Western/Scott Fetzer Company, with an inspection on August 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8a7736e1-62c6-4b20-8e53-c1a01aad8c8b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1064635
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Western/Scott Fetzer Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2018 | Not classified | Cincinnati District Office | |
| August 12, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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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