Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-08-02.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Aug 2021 | Foods & Cosmetics | Clean | |
| 8 Feb 2017 – 9 Feb 2017 | Foods & Cosmetics | Clean | |
| 18 Feb 2014 – 19 Feb 2014 | Foods & Cosmetics | 483 | View 483 → |
| 20 Sep 2011 | Not recorded | 483 | View 483 → |
| 9 Sep 2010 | Not recorded | WL | On file |
| 26 Mar 2008 | Not recorded | 483 | On file |
| 14 Sep 2007 | Not recorded | Clean | |
| 2 Mar 2005 | Not recorded | Clean | |
| 15 Jul 2003 | Not recorded | Clean | |
| 13 Jun 2002 | Not recorded | Clean | |
| 21 Jun 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.
Edna J Hidalgo2 insp.
Avery J Dennis1 insp.
Mabel M Lee1 insp.
Erica R Pomeroy1 insp.
James C Yee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ocean Fresh, LLC'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