FDA-Inspected Site

OCEANA USA INC

3 FDA inspections are on record for OCEANA USA INC in Irwindale, United States.

483· Form 483 issued

Irwindale, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-01.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Apr 2026 – 1 May 2026Foods & Cosmetics483View 483 →
14 May 2025 – 21 May 2025Foods & Cosmetics483View 483 →
11 May 2023 – 23 May 2023Foods & Cosmetics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

1 May 2026
21 CFR 1.511(c)(1)

No CGMPs - supplier approval, performance, risk

Cited by Terrance P Nguyen

21 May 2025
21 CFR 1.511(c)(1)

No CGMPs - supplier approval, performance, risk

Cited by Terrance P Nguyen

23 May 2023
21 CFR 1.502(a)

Develop FSVP

Cited by Terrance P Nguyen

23 May 2023
21 CFR 1.504(a)

Hazard analysis written

Cited by Terrance P Nguyen

23 May 2023
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Terrance P Nguyen

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1.511(c)(1)Cited across public-safe Form 483 observations3x
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.511(c)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.511(c)(5)(i)(A)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind OCEANA USA INC's 3 Form 483s

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