FDA Inspection
The Anspach Effort, Inc.The Anspach Effort, Inc. – FDA Inspection, Aug 21, 2013
Record Details
This FDA Inspection record concerns The Anspach Effort, Inc., with an inspection on August 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Anspach Effort, Inc.
- Inspection Date
- August 21, 2013
- Product Type
- Devices
View Company Profile
ID · 9ba38dc3-777e-473f-b29a-44e4a6b1c9cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848048
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
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 |
| 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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