Warning letter
Tropical Seas, Inc.: warning letter of May 15, 2019
FDA warning letter 562365 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 562365 |
|---|---|
| Company | Tropical Seas, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 15, 2019 |
| Posted date | Jun 11, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.34, 201.66, 211.192, 330.1, 201.66(b)(2), 211.160(b) |
| Inspection city | Holly Hill |
| Inspection ZIP | 32117 |
| Inspection start date | May 21, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: