FDA Inspection 950623 — Tropical Seas, Inc.
The FDA completed an inspection of Tropical Seas, Inc. on November 19, 2015 in Holly Hill, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holly Hill, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |