# FDA 483 - Tropical Seas, Inc. - February 12, 2026

Source: https://www.keypedia.com/records/483/tropical-seas-inc/bc175867-bbb9-49c6-ae09-734ccc760cf2

> FDA 483 for Tropical Seas, Inc. on February 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tropical Seas, Inc.
- Inspection Date: 2026-02-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2018-05-30](https://www.keypedia.com/records/483/tropical-seas-inc/32eb472d-6f42-42f6-ae88-2f4c3e928f9c)
- [WARNING_LETTER - 2018-05-30](https://www.keypedia.com/records/warning_letter/tropical-seas-inc/b9cd279b-b065-4945-8e21-e6a37beb1353)
- [483 - 2022-07-15](https://www.keypedia.com/records/483/tropical-seas-inc/26d94ad4-3624-4c3c-b216-2f6e0d4ce506)

## Related Officers

- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

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