FDA Inspection
Sterimed, LLCSterimed, LLC – FDA Inspection, Nov 6, 2013
Record Details
This FDA Inspection record concerns Sterimed, LLC, with an inspection on November 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sterimed, LLC
- Inspection Date
- November 6, 2013
- Product Type
- Devices
View Company Profile
ID · c96ce0d2-09fe-490c-93a8-e81f3cec2b0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855408
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of Sterimed, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sterimed, LLC
- FDA Inspection 1006535 - 2017-03-20
- FDA Inspection 716528 - 2011-03-14
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