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

During an FDA inspection from January 9-20, 2023, LXR Biotech, LLC, a manufacturer of drug products like CofixRx Nasal Spray, was cited for numerous deficiencies in its operations. The inspection revealed a lack of an independent quality control unit, with quality personnel performing both manufacturing and approval roles. Critical quality unit procedures were not formally documented or adhered to, often using protocols intended for dietary supplements rather than drug products. Significant issues were noted in documentation and record-keeping, including incomplete batch manufacturing records, improper corrections, and inconsistent lot coding. The company failed to adequately qualify suppliers for raw ingredients, notably for the active ingredient Povidone Iodine Solution. Laboratory controls were found to be insufficient, lacking scientifically sound specifications for final product release and appropriate testing methods for components and containers. Furthermore, LXR Biotech, LLC lacked established written procedures for production and process controls, neglecting process validation and equipment qualification. Labeling and packaging procedures were deficient, leading to instances of incorrect expiration dates on finished products. Batch production and control records were consistently incomplete, missing crucial details regarding personnel, equipment, and yield. These observations indicate non-compliance with current Good Manufacturing Practices (cGMP) for drug products. LXR Biotech, LLC is required to implement comprehensive corrective actions to resolve these systemic issues and ensure regulatory adherence.