FDA Inspection 1054156 — Tropical Seas, Inc.
The FDA completed an inspection of Tropical Seas, Inc. on May 30, 2018 in Holly Hill, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holly Hill, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |