# FDA 483 - Jardon Eye Prosthetics, Inc. - March 02, 2026

Source: https://www.keypedia.com/records/483/jardon-eye-prosthetics-inc/761c4beb-00d3-4cc6-bb8e-46e0c909108b

> FDA 483 for Jardon Eye Prosthetics, Inc. on March 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jardon Eye Prosthetics, Inc.
- Inspection Date: 2026-03-02
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Jardon Eye Prosthetics, Inc. in Southfield, MI, revealed significant deficiencies in their quality management system for medical device manufacturing. The firm failed to adequately document critical processes such as risk management, nonconforming product control, internal audits, supplier evaluation, equipment maintenance, and management reviews. These issues indicate a systemic lack of documented procedures and controls essential for ensuring product quality and regulatory compliance.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/jardon-eye-prosthetics-inc/1f88edfe-c537-4fde-97c2-ff887aebd73b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03