Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-06.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Dec 2022 | Foods & Cosmetics | Clean | |
| 25 Jun 2019 – 27 Jun 2019 | Foods & Cosmetics | 483 | View 483 → |
| 16 Feb 2016 – 17 Feb 2016 | Foods & Cosmetics | 483 | View 483 → |
| 16 Jul 2013 – 17 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 6 Jul 2011 | Not recorded | 483 | View 483 → |
| 16 Jun 2010 | Not recorded | Clean | |
| 1 Jul 2009 | Not recorded | 483 | View 483 → |
| 27 Jan 2005 | Not recorded | Clean | |
| 22 Jun 2004 | Not recorded | Clean | |
| 30 Apr 2003 | Not recorded | Clean | |
| 27 Sep 2001 | Not recorded | Clean | |
| 16 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sara J Dent Acosta2 insp.
Lilly O Barton1 insp.
Sean P Desbrow1 insp.
James P Stallings1 insp.
Joseph Brady1 insp.
Sarah A Hassas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ocean Jewels, Ltd's 5 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