Atlas

Form 483

Fabrica de Queso El Casero Form 483, 2011-10-04

FDA issued a Form 483 to Fabrica de Queso El Casero on 2011-10-04 with 3 public-safe observations.

483· Form 483 issued3 observations

Fabrica de Queso El Casero · Arecibo, United States · Issued October 4, 2011

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.

4 Oct 2011
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Adaliz Santaliz-Cruz

4 Oct 2011
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Adaliz Santaliz-Cruz

4 Oct 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Adaliz Santaliz-Cruz

Inspected site

FDFabrica de Queso El CaseroArecibo, United States

Inspection team

ASAdaliz Santaliz-Cruz

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 110.35(c)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