FDA Inspection 1342246 — Jeron Electronic Systems Inc.
The FDA completed an inspection of Jeron Electronic Systems Inc. on Oct 7, 2026 in Niles, IL. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 7, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |