FDA Inspection
Andersen Products, Inc.Andersen Products, Inc. – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns Andersen Products, Inc., with an inspection on July 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e115e71e-2128-4e52-b4fb-2d7d615f0b3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017867
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Andersen Products, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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