Form 483

Vitony Bakery, Inc. Form 483, 2019-08-09

FDA issued a Form 483 to Vitony Bakery, Inc. on 2019-08-09 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Vitony Bakery, Inc. · San Juan, United States · Issued August 9, 2019

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.

9 Aug 2019
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Eva I Merced Medina

9 Aug 2019
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Eva I Merced Medina

9 Aug 2019
21 CFR 117.135(b)

Preventive Controls - Written

Cited by Eva I Merced Medina

9 Aug 2019
21 CFR 117.135(b)

Preventive Controls - Written

Cited by Eva I Merced Medina

9 Aug 2019
21 CFR 117.35(c)

Pest Control

Cited by Eva I Merced Medina

Inspected site

VBVitony Bakery, Inc.San Juan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(b)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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