Indilab, Inc. – FDA 483, Feb 9, 2026

Indilab, Inc. in Franklin Park, IL, a manufacturer of medical devices, was cited with two observations during an FDA inspection. The inspection revealed inadequate planning and control in product design and development, specifically concerning process qualification for their Indistrip Steam Indicator. Additionally, the firm's Medical Device Reporting (MDR) procedure was found to be deficient, lacking proper documentation and recordkeeping requirements for reports and recall information submitted to the FDA.