Form 483

WB Frozen US, LLC Form 483, 2021-08-27

FDA issued a Form 483 to WB Frozen US, LLC on 2021-08-27 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

WB Frozen US, LLC · Brownsburg, United States · Issued August 27, 2021

Overview

  • 4 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.

27 Aug 2021
21 CFR 117.150(a)(1)

Sanitation Controls Corrective Action Proced: Estab Implemnt

Cited by Hans T Meyers, Vera M Anderson

27 Aug 2021
21 CFR 117.150(a)(1)

Sanitation Controls Corrective Action Proced: Estab Implemnt

Cited by Hans T Meyers, Vera M Anderson

27 Aug 2021
21 CFR 117.37

Sanitary facilities and controls

Cited by Hans T Meyers, Vera M Anderson

27 Aug 2021
21 CFR 117.37

Sanitary facilities and controls

Cited by Hans T Meyers, Vera M Anderson

Inspected site

WFWB Frozen US, LLCBrownsburg, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.150(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.37Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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