FDA Inspection
Sterimed, LLCSterimed, LLC – FDA Inspection, Mar 20, 2017
Record Details
This FDA Inspection record concerns Sterimed, LLC, with an inspection on March 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cbcc3842-56d4-46c0-b395-b4193b58055f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006535
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterimed, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sterimed, LLC
- FDA Inspection 855408 - 2013-11-06
- FDA Inspection 716528 - 2011-03-14
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