Form 483

Quesito El Establo Form 483, 2009-11-10

FDA issued a Form 483 to Quesito El Establo on 2009-11-10 with 3 public-safe observations.

483· Form 483 issued3 observations

Quesito El Establo · Peabody, United States · Issued November 10, 2009

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.

10 Nov 2009
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by John P Shelton

10 Nov 2009
21 CFR 110.80

Reasonable precautions

Cited by John P Shelton

10 Nov 2009
21 CFR 110.80(b)(5)

Work-in-progress

Cited by John P Shelton

Inspected site

QEQuesito El EstabloPeabody, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)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