FDA 483 - LXR Biotech, LLC - January 20, 2023

LXR Biotech, LLC, a manufacturer in Rochester Hills, MI, was inspected and cited for severe deficiencies in its quality control unit, laboratory controls, and production processes for drug products, specifically CofixRx Nasal Spray. The firm lacked independent quality oversight, failed to establish and follow written procedures for manufacturing and testing, and maintained incomplete batch records, indicating a fundamental breakdown in cGMP compliance.