Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-02.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jul 2023 – 2 Aug 2023 | Foods & Cosmetics | 483 | View 483 → |
| 6 Jun 2017 – 9 Jun 2017 | Foods & Cosmetics | 483 | View 483 → |
| 10 Aug 2016 | Foods & Cosmetics | Clean | |
| 7 Apr 2015 – 9 Apr 2015 | Foods & Cosmetics | 483 | View 483 → |
| 16 May 2012 | Not recorded | Clean | |
| 4 Mar 2010 | Not recorded | 483 | On file |
| 12 Jun 2009 | Not recorded | Clean | |
| 17 May 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2015
21 CFR 113.40(a)(2)(iii)
Adjusted to agree with TID
Cited by Nikisha M Bolden, Matthew R Noonan
Investigators
FDA investigators tied to this site in the record.
Gerald W Kopp2 insp.
Sean D Duke1 insp.
Ramanda C Gregory1 insp.
Mark A Jackson1 insp.
Whitney S Reynolds1 insp.
Nikisha M Bolden1 insp.
Matthew R Noonan1 insp.
Lauren N Shade1 insp.
Cynthia White1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.40(a)(2)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sea Watch International, Ltd.'s 4 Form 483s
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