FDA 483 - LiquidCapsule Manufacturing, LLC - July 03, 2025

LiquidCapsule Manufacturing, LLC, an OTC drug manufacturer in Tampa, FL, was cited for significant deficiencies during an FDA inspection from June 25 to July 3, 2025. The firm failed to establish adequate production and process controls, including process validation and equipment qualification, and exhibited critical issues with cleaning validation and procedures. Additionally, the inspection revealed non-contemporaneous batch records, a lack of an ongoing stability program, inadequate component identity testing, and a quality control unit that did not fully follow its responsibilities or ensure cGMP compliance.