Atlas

Form 483

Leon's Pastries, Inc. Form 483, 2017-02-09

FDA issued a Form 483 to Leon's Pastries, Inc. on 2017-02-09 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Leon's Pastries, Inc. · Madison Heights, United States · Issued February 9, 2017

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.

9 Feb 2017
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Michelle L Jones

9 Feb 2017
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Michelle L Jones

Inspected site

LPLeon's Pastries, Inc.Madison Heights, United States

Inspection team

MLMichelle L Jones

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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