FDA 483 - ISOVAC Products, LLC - February 10, 2026

ISOVAC Products, LLC in Romeoville, IL, a manufacturer of Portable Patient Isolation Units (CAPSULS), was inspected by the FDA and received eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate risk management, design control failures, lack of corrective actions for previous nonconformities, insufficient supplier controls, and non-compliance with UDI labeling and registration requirements. The firm also failed to conduct internal audits as required.