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Facility profile

Tropical Seas, Inc.

Drug product manufacturing · Holly Hill, FL

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Manufacture
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Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Feb 12, 2026 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2019

More than five years old · review later records.

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Shows

Registration status and a latest matched official action indicated inspection.

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Method and source details
View full inspection and compliance history9 inspection records

FDA inspection history

9 records, Nov 2010 – Feb 2026 · 1 NAI · 5 VAI · 3 OAI

DateClassProject areaCitationsFY
Feb 12, 2026OAIDrug Quality AssuranceYes2026
Jul 15, 2022OAIDrug Quality AssuranceYes2022
May 30, 2018OAIDrug Quality AssuranceYes2018
Nov 19, 2015VAIUnapproved and Misbranded DrugsYes2016
Nov 19, 2015VAIDrug Quality AssuranceYes2016
Feb 6, 2012VAIDrug Quality AssuranceYes2012
Feb 6, 2012VAIColors and Cosmetics TechnologyYes2012
Nov 24, 2010NAIColors and Cosmetics Technology2011
Nov 24, 2010VAIDrug Quality Assurance2011

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

May 15, 2019Warning Letter · CDER
Unclaimed profile

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