FDA 483 - ISOVAC Products, LLC - May 11, 2023

An FDA inspection of ISOVAC Products, LLC in Romeoville, IL, a manufacturer of CAPSULS Patient Isolation Units, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures for accepting in-process products, specifically regarding alarm testing for blowers. Additionally, the inspection found a lack of established procedures for supplier evaluation and control, and a failure to adequately document corrective and preventive action effectiveness checks.