Form 483

Empire Fresh Produce Form 483, 2022-02-18

FDA issued a Form 483 to Empire Fresh Produce on 2022-02-18 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Empire Fresh Produce · Dallas, United States · Issued February 18, 2022

Overview

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

Inspectional observations

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

18 Feb 2022
21 CFR 1.502(a)

Develop FSVP

Cited by Sandra Jacquez

18 Feb 2022
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Sandra Jacquez

18 Feb 2022
21 CFR 1.510(b)(1)

Record - translate to English

Cited by Sandra Jacquez

Inspected site

EFEmpire Fresh ProduceDallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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