FDA Inspection
Aspen Surgical Products, Inc.Aspen Surgical Products, Inc. – FDA Inspection, Feb 26, 2010
Record Details
This FDA Inspection record concerns Aspen Surgical Products, Inc., with an inspection on February 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 26, 2010
- Product Type
- Devices
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ID · 68f5977b-cc95-46c7-9040-cdf028b97543
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653652
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(a)(1)Process control instructions
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Other FDA inspections of Aspen Surgical Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aspen Surgical Products, Inc.
- FDA Inspection 1031151 - 2017-11-08
- FDA Inspection 913454 - 2015-02-11
- FDA Inspection 820190 - 2013-02-15
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