FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, Aug 9, 2013
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on August 9, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smiths Medical ASD, Inc.
- Inspection Date
- August 9, 2013
- Product Type
- Devices
View Company Profile
ID · 80bc42da-30c6-431e-a84e-ef59021046fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Smiths Medical ASD, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smiths Medical ASD, Inc.
- FDA Inspection 973823 - 2016-06-10
- FDA Inspection 683114 - 2010-09-30
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