FDA 483 - BioRamo, LLC - January 30, 2025

An FDA inspection of BioRamo, LLC, a drug manufacturer in Ft Lauderdale, FL, revealed significant deficiencies in its quality control unit and material handling systems. The firm failed to adequately document investigations, ensure proper product release, and maintain effective inventory control, leading to potential contamination and mix-ups. These issues indicate a lack of adherence to good manufacturing practices.