Company
United StatesPro-Optics LLC, Palatine, IL – FDA Inspections
Inspection records and compliance data for Pro-Optics LLC in Palatine, Illinois. 2 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected March 11, 2026.
Company Profile
This profile covers Pro-Optics LLC based in Palatine, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected January 3, 2018. Last inspected March 11, 2026.
Most cited issue areas
- Changes to the QMS not adequately controlled or evaluated1 inspection
- Design and development procedures not documented1 inspection
- Procedures for purchasing process not documented1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 11, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1306858 |
| January 3, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1037062 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pro-Optics LLC
FEI Number
1419844
Address
317 N Woodwork Ln, Palatine, Illinois 60067, United States
Country
United States
ID: 1af19013-8abc-4d39-91b8-22cd3cce82f0