FDA Inspection
The Anspach Effort, Inc.The Anspach Effort, Inc. – FDA Inspection, May 22, 2012
Record Details
This FDA Inspection record concerns The Anspach Effort, Inc., with an inspection on May 22, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Anspach Effort, Inc.
- Inspection Date
- May 22, 2012
- Product Type
- Devices
View Company Profile
ID · 5b7e1b39-0e2b-4b52-bee7-5d289fe55810
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787702
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.20(b)(3)Events
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
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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 |
| August 26, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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