FDA 483 - BioRamo, LLC - January 30, 2025

BioRamo, LLC, a drug manufacturer in Ft Lauderdale, FL, was inspected by the FDA and cited for significant deficiencies. The firm's quality control unit failed to follow written procedures, specifically regarding inadequate investigations and lack of documented final product release. Additionally, the inspection revealed failures in handling and storing materials, leading to potential contamination risks due to poor inventory tracking and insufficient storage procedures.