FDA 483 - LiquidCapsule Manufacturing, LLC - February 09, 2024

LiquidCapsule Manufacturing, LLC in Tampa, FL, was cited for significant deficiencies in its manufacturing and quality control processes for OTC drug products. The inspection revealed a lack of fundamental procedures, including process and cleaning validation, equipment qualification, and adequate quality unit oversight. These issues indicate a severe lack of control over product quality, identity, strength, and purity.