FDA Inspection
C&W Swiss IncC&W Swiss Inc – FDA Inspection, Apr 12, 2019
Record Details
This FDA Inspection record concerns C&W Swiss Inc, with an inspection on April 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dabf3c1f-cda8-4d71-a21a-c39e27f7ea23
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086302
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| November 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for C&W Swiss Inc
- FDA Inspection 1244468 - 2024-07-17
- FDA Inspection 951951 - 2015-11-19
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