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

Source: https://www.keypedia.com/records/483/tropical-seas-inc/32eb472d-6f42-42f6-ae88-2f4c3e928f9c

> FDA 483 for Tropical Seas, Inc. on May 30, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Tropical Seas, Inc.
- Inspection Date: 2018-05-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [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)
- [483 - 2026-02-12](https://www.keypedia.com/records/483/tropical-seas-inc/bc175867-bbb9-49c6-ae09-734ccc760cf2)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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