FDA Inspection 1306858 — Pro-Optics LLC
The FDA completed an inspection of Pro-Optics LLC on Mar 11, 2026 in Palatine, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palatine, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23109 | ISO 13485:2016 Clause 7.3.4 | Records of design and development outputs not maintained |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |