FDA 483 - Belleview 402 LLC - August 20, 2021

TG United Inc, an OTC drug manufacturer in Brooksville, FL, was cited for significant deficiencies across its quality system, laboratory controls, and facilities and equipment. The inspection revealed a pervasive lack of cGMP implementation, inadequate quality oversight, and unvalidated test methods, leading to the release of unverified drug products. Repeated observations from previous inspections indicate a systemic failure to address critical compliance issues, particularly concerning water systems and cleaning validations.