FDA Inspection
The Anspach Effort, Inc.The Anspach Effort, Inc. – FDA Inspection, Feb 6, 2015
Record Details
This FDA Inspection record concerns The Anspach Effort, Inc., with an inspection on February 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Anspach Effort, Inc.
- Inspection Date
- February 6, 2015
- Product Type
- Devices
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ID · 6ed1ebc6-35d8-4057-bab5-76c660244cea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 913270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of The Anspach Effort, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 22, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 26, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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