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# CGMP Violations at Tropical Seas
- URL: https://www.fdaweb.com/cgmp-violations-at-tropical-seas/
- Published: 2019-06-18T12:00:00.000Z
- Updated: 2026-09-15T01:33:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144355

A 5/12-5/30/18 FDA inspection at the Tropical Seas drug manufacturing facility in Holly Hill, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 5/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tropical-seas-inc-562365-05152019?ref=fdaweb.com) also says the firm produces several products that the agency considers to be unapproved new drugs. Specific CGMP violations were: 

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed.

FDA recommends that Tropical Seas engage a qualified consultant to assist it in meeting CGMP requirements.

The agency also says the company manufactures drug products containing glycerin and it is unclear if the firm has addressed whether diethylene or ethylene glycol is within appropriate limits according to United States Pharmacopeia standards for glycerin lots used to manufacture its over-the-counter drug products.

Finally, the letter discusses unapproved new drug and misbranding concerns for five of the company’s products.

Tropical Seas was told to take prompt action to correct the violations and prevent their recurrence and was told to respond with a list of specific steps taken since the inspection, with a timetable for completion.