FDA Inspection
Tropical Seas, Inc.Tropical Seas, Inc. – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns Tropical Seas, Inc., with an inspection on November 19, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tropical Seas, Inc.
- Inspection Date
- November 19, 2015
- Product Type
- Drugs
View Company Profile
ID · b5ba525e-2053-4c1d-a207-f9451ed914cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 950623
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
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Other FDA inspections of Tropical Seas, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2026 | OAI | Florida District Office | Drug Quality Assurance |
| 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 |
| 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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