FDA Inspection
Morgan Scientific, Inc.Morgan Scientific, Inc. – FDA Inspection, May 15, 2017
Record Details
This FDA Inspection record concerns Morgan Scientific, Inc., with an inspection on May 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7e379a8b-3763-4c8f-ba5d-53d13a45a23f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013207
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Morgan Scientific, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Morgan Scientific, Inc.
- FDA Inspection 791778 - 2012-07-10
- FDA Inspection 728763 - 2011-06-10
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