Form 483

LE BUS WHOLESALE BAKERY, INC Form 483, 2020-02-14

FDA issued a Form 483 to LE BUS WHOLESALE BAKERY, INC on 2020-02-14 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

LE BUS WHOLESALE BAKERY, INC · King Of Prussia, United States · Issued February 14, 2020

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

14 Feb 2020
21 CFR 117.135(c)(1)

Process Controls Procedures - Adequate

Cited by Meredith L Sheridan

14 Feb 2020
21 CFR 117.135(c)(1)

Process Controls Procedures - Adequate

Cited by Meredith L Sheridan

14 Feb 2020
21 CFR 117.135(c)(2)

Allergen Controls Procedures

Cited by Meredith L Sheridan

14 Feb 2020
21 CFR 117.135(c)(2)

Allergen Controls Procedures

Cited by Meredith L Sheridan

14 Feb 2020
21 CFR 117.135(c)(3)

Sanitation Controls Procedures

Cited by Meredith L Sheridan

Inspected site

LBLE BUS WHOLESALE BAKERY, INCKing Of Prussia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations2x
21 CFR 117.145(a)Cited across public-safe Form 483 observations2x
21 CFR 117.165(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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