FDA Inspection
Rauland-Borg CorpRauland-Borg Corp – FDA Inspection, Oct 25, 2012
Record Details
This FDA Inspection record concerns Rauland-Borg Corp, with an inspection on October 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rauland-Borg Corp
- Inspection Date
- October 25, 2012
- Product Type
- Devices
View Company Profile
ID · 60c048f6-398d-4695-aad6-a8f78edbadf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803717
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Rauland-Borg Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 29, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rauland-Borg Corp
- FDA Inspection 976432 - 2016-05-26
- FDA Inspection 700011 - 2010-11-29
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