FDA 483 - CellTrans Inc. - June 11, 2021

An FDA inspection of CellTrans Islet Isolation facility in Chicago, IL, revealed significant deficiencies across its quality unit, aseptic processing, and manufacturing controls. The firm was cited for issues including inadequate sterilization oversight, deficient deviation reporting, release of non-conforming product lots, and poor environmental controls. These observations highlight a systemic lack of adherence to established quality standards and procedures.