Tropical Seas, Inc. – FDA 483, Feb 12, 2026

Tropical Seas, Inc., an OTC manufacturer in Holly Hill, FL, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight severe issues across laboratory controls, microbial contamination prevention, stability programs, investigation processes, facility sanitation, equipment calibration, quality control procedures, and employee training. These findings indicate a broad lack of adherence to current good manufacturing practices.