Form 483

Shimons Bakery Inc. Form 483, 2024-02-21

FDA issued a Form 483 to Shimons Bakery Inc. on 2024-02-21 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Shimons Bakery Inc. · Newburgh, United States · Issued February 21, 2024

Overview

  • 2 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.

21 Feb 2024
21 CFR 117.10

Personnel

Cited by Frank J Koch, Terry E Pierre

21 Feb 2024
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Frank J Koch, Terry E Pierre

Inspected site

SBShimons Bakery Inc.Newburgh, United States

Inspection team

TETerry E Pierre

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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