FDA Inspection
Ferno-Washington IncFerno-Washington Inc – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Ferno-Washington Inc, with an inspection on September 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ferno-Washington Inc
- Inspection Date
- September 29, 2011
- Product Type
- Devices
View Company Profile
ID · dd9736c0-99a9-407b-a847-dee156704865
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 744780
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Ferno-Washington Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2026 | Not classified | Cincinnati District Office | |
| January 24, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 11, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ferno-Washington Inc
- FDA Inspection 1337050 - 2026-09-09
- FDA Inspection 1195616 - 2023-01-24
- FDA Inspection 1061517 - 2018-07-23
- FDA Inspection 913076 - 2015-03-11
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