FDA Inspection
The Anspach Effort, Inc.The Anspach Effort, Inc. – FDA Inspection, Aug 26, 2011
Record Details
This FDA Inspection record concerns The Anspach Effort, Inc., with an inspection on August 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Anspach Effort, Inc.
- Inspection Date
- August 26, 2011
- Product Type
- Devices
View Company Profile
ID · 948d9c38-3031-4481-afd8-8a337f6dbeaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741539
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, 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 |
|---|---|---|---|
| February 6, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
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