FDA Inspection
Innovative Surgical Designs, Inc.Innovative Surgical Designs, Inc. – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Innovative Surgical Designs, Inc., with an inspection on April 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6693bfc2-cb9b-4014-97e4-0880f49d0db4
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1049811
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Innovative Surgical Designs, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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