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Form 483

BENDE INC. Form 483, 2023-12-22

FDA issued a Form 483 to BENDE INC. on 2023-12-22 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

BENDE INC. · Vernon Hills, United States · Issued December 22, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

22 Dec 2023
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Davyd D Fytsyk Kravets

22 Dec 2023
21 CFR 1.506(d)(1)(ii)

Verification activity - appropriate

Cited by Davyd D Fytsyk Kravets

Inspected site

BIBENDE INC.Vernon Hills, United States

Inspection team

DDDavyd D Fytsyk Kravets

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(d)(1)(ii)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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