# Pro-Optics LLC – FDA 483, Mar 11, 2026

Source: https://www.keypedia.com/records/483/pro-optics-llc/ca22b3dd-75d8-44f1-a799-305f62ce6cd2

> FDA 483 for Pro-Optics LLC on March 11, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pro-Optics LLC
- Inspection Date: 2026-03-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Pro-Optics LLC in Palatine, IL, a manufacturer of Class II contact lens cases, revealed significant deficiencies across its quality management system. The firm failed to establish and maintain adequate design controls, including documentation for design changes and transfer, and did not maintain essential design output records. Additionally, Pro-Optics LLC did not properly control changes to its manufacturing processes or adequately evaluate and approve contract manufacturers, posing a substantial risk to device quality.

## Related Documents

- [WARNING_LETTER - 2026-03-11](https://www.keypedia.com/records/warning_letter/pro-optics-llc/1893ba03-4411-49d4-931d-83b3530a4d9c) — date: March 11, 2026

## Related Officers

- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/pro-optics-llc/1af19013-8abc-4d39-91b8-22cd3cce82f0

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669