FDA Inspection
EEG Software LLCEEG Software LLC – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns EEG Software LLC, with an inspection on August 27, 2026, issued by the Florida District Office, covering medical devices & rad health.
- Office
- Florida District Office
- Person
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ID · fb7134c4-8cce-44a0-937c-f9742b2651eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1333128
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EEG Software LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for EEG Software LLC
- FDA Inspection 975478 - 2016-06-16
- FDA Inspection 846643 - 2013-08-27
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