Form 483

Chang & Son Enterprises, Inc. Form 483, 2025-01-07

FDA issued a Form 483 to Chang & Son Enterprises, Inc. on 2025-01-07 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Chang & Son Enterprises, Inc. · Whately, United States · Issued January 7, 2025

Overview

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

Inspectional observations

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

7 Jan 2025
21 CFR 112.145(b)

Targeted to Listeria or L. monocytogenes

Cited by John P Shelton, Osama A Khatib, Nasser Yazdani

7 Jan 2025
21 CFR 112.150(b)(6)

Documentation of corrective actions taken

Cited by John P Shelton, Osama A Khatib, Nasser Yazdani

Inspected site

C&Chang & Son Enterprises, Inc.Whately, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 112.145(b)Cited across public-safe Form 483 observations1x
21 CFR 112.150(b)(6)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