FDA Inspection
C&W Swiss IncC&W Swiss Inc – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns C&W Swiss Inc, with an inspection on November 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- C&W Swiss Inc
- Inspection Date
- November 19, 2015
- Product Type
- Devices
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ID · 34ebb8a2-236b-4d20-86c4-227b62f357c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951951
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of C&W Swiss Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for C&W Swiss Inc
- FDA Inspection 1244468 - 2024-07-17
- FDA Inspection 1086302 - 2019-04-12
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