Form 483

New York Bakeries, Inc. Form 483, 2012-03-27

FDA issued a Form 483 to New York Bakeries, Inc. on 2012-03-27 with 8 public-safe observations.

483· Form 483 issued8 observations

New York Bakeries, Inc. · Hialeah, United States · Issued March 27, 2012

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

27 Mar 2012
21 CFR 110.10(b)(4)

Hand jewelry - remove/cover

Cited by Adriana D Perez

27 Mar 2012
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Adriana D Perez

27 Mar 2012
21 CFR 110.20(b)(1)

Sufficient space

Cited by Adriana D Perez

27 Mar 2012
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Adriana D Perez

27 Mar 2012
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Adriana D Perez

Inspected site

NYNew York Bakeries, Inc.Hialeah, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
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 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)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 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