Form 483

Star Bakery, Inc. Form 483, 2024-12-05

FDA issued a Form 483 to Star Bakery, Inc. on 2024-12-05 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Star Bakery, Inc. · Miami, United States · Issued December 5, 2024

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.

5 Dec 2024
21 CFR 117.10

Personnel

Cited by David P King, Brittany C Smith

5 Dec 2024
21 CFR 117.20(a)

Grounds

Cited by David P King, Brittany C Smith

5 Dec 2024
21 CFR 117.20(b)

Plant construction and design

Cited by David P King, Brittany C Smith

5 Dec 2024
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by David P King, Brittany C Smith

Inspected site

SBStar Bakery, Inc.Miami, United States

Inspection team

DPDavid P King

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.20(a)Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)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