Form 483

Amphora International, Inc. Form 483, 2026-04-03

FDA issued a Form 483 to Amphora International, Inc. on 2026-04-03 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Amphora International, Inc. · Brea, United States · Issued April 3, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Apr 2026
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Elizabeth E Dominguez, Olubukola A Banmeke

3 Apr 2026
21 CFR 1.506(e)(1)(i)(B)

Audit - food safety regulation, plan

Cited by Elizabeth E Dominguez, Olubukola A Banmeke

Inspected site

AIAmphora International, Inc.Brea, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)(i)(B)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere