FDA Inspection
Smiths Medical Asd IncSmiths Medical Asd Inc – FDA Inspection, Apr 25, 2016
Record Details
This FDA Inspection record concerns Smiths Medical Asd Inc, with an inspection on April 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smiths Medical Asd Inc
- Inspection Date
- April 25, 2016
- Product Type
- Devices
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ID · af204800-fb99-45ee-ab69-3c6af99b964d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971811
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
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Other FDA inspections of Smiths Medical Asd Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Smiths Medical Asd Inc
- FDA Inspection 915186 - 2015-03-02
- FDA Inspection 749550 - 2011-10-14
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