Form 483

Foodworks International LLC Form 483, 2024-07-02

FDA issued a Form 483 to Foodworks International LLC on 2024-07-02 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Foodworks International LLC · Belleair Bluffs, United States · Issued July 2, 2024

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

2 Jul 2024
21 CFR 1.502(a)

Develop FSVP

Cited by Laura M Lopez

2 Jul 2024
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by Laura M Lopez

2 Jul 2024
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Laura M Lopez

2 Jul 2024
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Laura M Lopez

2 Jul 2024
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by Laura M Lopez

Inspected site

FIFoodworks International LLCBelleair Bluffs, 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(d)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(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 1.512(b)(1)(i)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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