FDA 483 - Oxford Pharmaceuticals, LLC - November 03, 2023

An FDA inspection of Oxford Pharmaceuticals, LLC in Birmingham, AL, revealed significant deficiencies in equipment cleaning and maintenance, quality control investigations, production phase time limits, and laboratory water testing. These issues indicate a lack of adequate controls to prevent contamination, ensure product quality, and properly address product complaints. The findings suggest a need for comprehensive corrective actions to bring the facility into compliance with cGMP regulations.