FDA Inspection
iScreen Vision, Inc.iScreen Vision, Inc. – FDA Inspection, Sep 28, 2023
Record Details
This FDA Inspection record concerns iScreen Vision, Inc., with an inspection on September 28, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · da267491-7a64-4f24-be91-d14e321a99b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219047
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of iScreen Vision, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for iScreen Vision, Inc.
- FDA Inspection 911600 - 2015-01-28
- FDA Inspection 760707 - 2011-12-21
- FDA Inspection 551252 - 2008-12-02
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