FDA 483 - Tropical Seas, Inc. - May 30, 2018

Tropical Seas, Inc. in Holly Hill, FL, was inspected and cited for multiple significant deficiencies across its quality, facilities, laboratory, and production systems. Observations included inadequate investigation of consumer complaints, lack of documented employee training, poor equipment maintenance leading to potential contamination, and deficient laboratory and production controls. These issues indicate a systemic failure to adhere to current good manufacturing practices.