FDA Inspection 1333128 — EEG Software LLC
The FDA completed an inspection of EEG Software LLC on Aug 27, 2026 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |