Tropical Seas, Inc. – FDA 483, Jul 15, 2022

An FDA inspection of Tropical Seas, Inc., an OTC drug manufacturer in Holly Hill, FL, revealed significant deficiencies across its quality control, laboratory, stability, and equipment systems. The firm failed to implement adequate cGMP systems, perform essential product testing, maintain an ongoing stability program, and ensure proper equipment maintenance and water system validation. Several critical issues, including unsuitable test methods and inadequate growth promotion, were repeat observations from a prior warning letter.