FDA Inspection
Innovative Surgical Designs, Inc.Innovative Surgical Designs, Inc. – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Innovative Surgical Designs, Inc., with an inspection on July 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 859f2ed0-d488-4e9d-845c-6d4c7e80736d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019901
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Innovative Surgical Designs, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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