FDA Inspection
Tropical Seas, Inc.Tropical Seas, Inc. – FDA Inspection, Feb 12, 2026
Record Details
This FDA Inspection record concerns Tropical Seas, Inc., with an inspection on February 12, 2026, issued by the Florida District Office, covering human drugs.
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ID · 88e898ec-84c4-4f1d-8f08-43b59dd72f9e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1304354
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Tropical Seas, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 6, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 24, 2010 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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