# FDA 483 - Tropical Seas, Inc. - July 15, 2022

Source: https://www.keypedia.com/records/483/tropical-seas-inc/26d94ad4-3624-4c3c-b216-2f6e0d4ce506

> FDA 483 for Tropical Seas, Inc. on July 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tropical Seas, Inc.
- Inspection Date: 2022-07-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2018-05-30](https://www.keypedia.com/records/warning_letter/tropical-seas-inc/b9cd279b-b065-4945-8e21-e6a37beb1353)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Senior Manager, Executive Secretariat ](https://www.keypedia.com/people/jessica-m-simpson/94c06709-45cf-464f-92b4-ad3601ea20ab)

Company: https://www.keypedia.com/companies/tropical-seas-inc/3a44dd93-cc29-4914-a3ab-d84393cb9293

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6