FDA Inspection
Vyaire MedicalVyaire Medical – FDA Inspection, Sep 5, 2012
Record Details
This FDA Inspection record concerns Vyaire Medical, with an inspection on September 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vyaire Medical
- Inspection Date
- September 5, 2012
- Product Type
- Devices
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ID · 4349dd01-cb61-4158-a86e-02b9e0873c90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801998
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Vyaire Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vyaire Medical
- FDA Inspection 899913 - 2014-09-30
- FDA Inspection 754525 - 2011-11-25
- FDA Inspection 614960 - 2009-09-18
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