Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-12.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 12 Feb 2026 | Human Drugs | 483 | On file |
| 11 Jul 2022 – 15 Jul 2022 | Human Drugs | 483 | View 483 → |
| 21 May 2018 – 30 May 2018 | Human Drugs | WL | View 483 → |
| 9 Nov 2015 – 19 Nov 2015 | Human Drugs | 483 | View 483 → |
| 6 Feb 2012 | Not recorded | 483 | View 483 → |
| 24 Nov 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Saundrea A Munroe, Jessica M Simpson
15 Jul 2022
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Saundrea A Munroe, Jessica M Simpson
15 Jul 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saundrea A Munroe, Jessica M Simpson
15 Jul 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Saundrea A Munroe, Jessica M Simpson
15 Jul 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Saundrea A Munroe, Jessica M Simpson
Investigators
FDA investigators tied to this site in the record.
Saundrea A Munroe2 insp.
Angela E Glenn2 insp.
Lori M Newman1 insp.
Jessica M Simpson1 insp.
Jessica L Pressley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tropical Seas, Inc.'s 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat