FDA Inspection
Stentys Inc.Stentys Inc. – FDA Inspection, Feb 26, 2015
Record Details
This FDA Inspection record concerns Stentys Inc., with an inspection on February 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stentys Inc.
- Inspection Date
- February 26, 2015
- Product Type
- Devices
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ID · 8ef98063-4595-43e7-a4e0-245d6ea05e49
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 919512
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
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