FDA Inspection
Smiths Medical ASD, Inc.Smiths Medical ASD, Inc. – FDA Inspection, May 9, 2019
Record Details
This FDA Inspection record concerns Smiths Medical ASD, Inc., with an inspection on May 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · e17ba65b-24c2-4160-ac5a-4db5f2f47a8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089006
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Smiths Medical ASD, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smiths Medical ASD, Inc.
- FDA Inspection 1223285 - 2023-11-02
- FDA Inspection 1030576 - 2017-10-19
- FDA Inspection 923970 - 2015-03-30
- FDA Inspection 798847 - 2012-09-14
- FDA Inspection 696353 - 2010-10-12
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