FDA Inspection
Aspen Surgical Products, Inc.Aspen Surgical Products, Inc. – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns Aspen Surgical Products, Inc., with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 91215db5-443a-4cca-a477-a66e26e78eac
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1031151
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Aspen Surgical Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aspen Surgical Products, Inc.
- FDA Inspection 913454 - 2015-02-11
- FDA Inspection 820190 - 2013-02-15
- FDA Inspection 653652 - 2010-02-26
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