Lentigen Technology, Inc. – FDA 483, May 3, 2024

An FDA inspection of Lentigen Technology, Inc. in Gaithersburg, MD, identified significant deficiencies in the testing and qualification of raw materials used in the manufacturing of their MAGE-A4-c1032 lentiviral vector. The firm failed to adequately test and qualify critical raw materials and consumables, including issues with Certificate of Analysis testing and visual inspection procedures. These observations indicate a lack of robust quality control over essential manufacturing inputs.