FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, Dec 10, 2013
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on December 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smiths Medical ASD, Inc.
- Inspection Date
- December 10, 2013
- Product Type
- Devices
View Company Profile
ID · 626b70b0-2e52-4c16-b564-b3a7a9b57fa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858645
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Smiths Medical ASD, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smiths Medical ASD, Inc.
- FDA Inspection 709460 - 2011-01-28
- FDA Inspection 671229 - 2010-06-08
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