FDA Inspection
STERIMED, Inc.STERIMED, Inc. – FDA Inspection, Dec 14, 2016
Record Details
This FDA Inspection record concerns STERIMED, Inc., with an inspection on December 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e660d864-83a2-4933-8266-900b541b09ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996126
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of STERIMED, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for STERIMED, Inc.
- FDA Inspection 850702 - 2013-09-27
- FDA Inspection 638180 - 2010-01-13
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