FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smiths Medical ASD, Inc.
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · e1a1731a-7ada-42eb-9d9c-ed5155b3ced9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709460
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Smiths Medical ASD, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2013 | 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 858645 - 2013-12-10
- FDA Inspection 671229 - 2010-06-08
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