Form 483

Vitony Bakery, Inc. Form 483, 2016-02-01

FDA issued a Form 483 to Vitony Bakery, Inc. on 2016-02-01 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Vitony Bakery, Inc. · San Juan, United States · Issued February 1, 2016

Overview

  • 4 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.

1 Feb 2016
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Loreily Figueroa Agrinsoni

1 Feb 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Loreily Figueroa Agrinsoni

1 Feb 2016
21 CFR 110.80(a)(1)

Storage

Cited by Loreily Figueroa Agrinsoni

1 Feb 2016
21 CFR 110.80(a)(6)

Thawed appropriately

Cited by Loreily Figueroa Agrinsoni

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 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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