Form 483

Quesito El Establo Form 483, 2016-05-17

FDA issued a Form 483 to Quesito El Establo on 2016-05-17 with 17 public-safe observations.

483· Form 483 issuedFoods & Cosmetics17 observations

Quesito El Establo · Peabody, United States · Issued May 17, 2016

Overview

  • 17 public-safe observations are available for this inspection.
  • 17 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.

17 May 2016
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Thomas Siebertz

17 May 2016
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Thomas Siebertz

17 May 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Thomas Siebertz

17 May 2016
21 CFR 110.35(a)

Buildings/good repair

Cited by Thomas Siebertz

17 May 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Thomas Siebertz

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)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 17 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