FDA Inspection
Innovative Surgical Designs, Inc.Innovative Surgical Designs, Inc. – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns Innovative Surgical Designs, Inc., with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 27, 2015
- Product Type
- Devices
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ID · bb086a4a-166e-4730-89fd-c1c94c218de5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940153
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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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 |
| July 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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