Form 483

Vitony Bakery, Inc. Form 483, 2011-03-25

FDA issued a Form 483 to Vitony Bakery, Inc. on 2011-03-25 with 5 public-safe observations.

483· Form 483 issued5 observations

Vitony Bakery, Inc. · San Juan, United States · Issued March 25, 2011

Overview

  • 5 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.

25 Mar 2011
21 CFR 110.20(b)(1)

Sufficient space

Cited by Ana M Rivera

25 Mar 2011
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Ana M Rivera

25 Mar 2011
21 CFR 110.35(a)

Buildings/sanitary

Cited by Ana M Rivera

25 Mar 2011
21 CFR 110.40(a)

Precluding contaminants

Cited by Ana M Rivera

25 Mar 2011
21 CFR 110.80(a)(1)

Inspection, segregation, handling of raw materials

Cited by Ana M Rivera

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)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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