Form 483

Star Bakery, Inc. Form 483, 2009-02-27

FDA issued a Form 483 to Star Bakery, Inc. on 2009-02-27 with 4 public-safe observations.

483· Form 483 issued4 observations

Star Bakery, Inc. · Miami, United States · Issued February 27, 2009

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Feb 2009
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Edwin J Gorney, Suzanne A Ramirez

27 Feb 2009
21 CFR 110.35(a)

Buildings/sanitary

Cited by Edwin J Gorney, Suzanne A Ramirez

27 Feb 2009
21 CFR 110.35(b)(1)

Unacceptable toxic compounds

Cited by Edwin J Gorney, Suzanne A Ramirez

27 Feb 2009
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Edwin J Gorney, Suzanne A Ramirez

Inspected site

SBStar Bakery, Inc.Miami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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