FDA Inspection 1282390 — Lights' Prosthetic Eyes Inc
The FDA completed an inspection of Lights' Prosthetic Eyes Inc on September 19, 2025 in Peoria, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Peoria, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |