JERON ELECTRONIC SYSTEMS INC — FDA Facility Profile
JERON ELECTRONIC SYSTEMS INC is an FDA-registered facility (FEI 3014653127) located in Niles, IL, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 7, 2026: No Action Indicated (NAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 7, 2026 | No Action Indicated (NAI) | Product realization risk management processes not documented (ISO 13485:2016 Clause 7.1) Complaint handling procedures not documented (ISO 13485:2016 Clause 8.2.2) |
| Dec 4, 2024 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.100(b)) |
| Jun 20, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate procedures (21 CFR 820.100(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) and 4 more |
Facility details
- Company
- Jeron Electronic Systems Inc.
- Location
- Niles, IL (US)
- Source
- device