Atlas

Form 483

Sweet Ann Cakes, Inc. Form 483, 2012-07-21

FDA issued a Form 483 to Sweet Ann Cakes, Inc. on 2012-07-21 with 3 public-safe observations.

483· Form 483 issued3 observations

Sweet Ann Cakes, Inc. · Toa Baja, United States · Issued July 21, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

21 Jul 2012
21 CFR 110.10(b)(6)

Failure to wear

Cited by Zuleika A Pineiro Vargas

21 Jul 2012
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Zuleika A Pineiro Vargas

21 Jul 2012
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Zuleika A Pineiro Vargas

Inspected site

SASweet Ann Cakes, Inc.Toa Baja, United States

Inspection team

ZAZuleika A Pineiro Vargas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)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 3 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