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Form 483

LE BUS WHOLESALE BAKERY, INC Form 483, 2017-02-27

FDA issued a Form 483 to LE BUS WHOLESALE BAKERY, INC on 2017-02-27 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

LE BUS WHOLESALE BAKERY, INC · King Of Prussia, United States · Issued February 27, 2017

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

27 Feb 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Derek S Dealy

27 Feb 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Derek S Dealy

27 Feb 2017
21 CFR 123.6(c)(2)

Critical control points

Cited by Derek S Dealy

27 Feb 2017
21 CFR 123.6(c)(2)

Critical control points

Cited by Derek S Dealy

27 Feb 2017
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Derek S Dealy

Inspected site

LBLE BUS WHOLESALE BAKERY, INCKing Of Prussia, United States

Inspection team

DSDerek S Dealy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations2x
21 CFR 123.6(d)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 8 observations

The source PDF and every observation in full, 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