Form 483

Marquez Bakery of Odessa, Inc Form 483, 2017-08-24

FDA issued a Form 483 to Marquez Bakery of Odessa, Inc on 2017-08-24 with 14 public-safe observations.

483· Form 483 issuedFoods & Cosmetics14 observations

Marquez Bakery of Odessa, Inc · Odessa, United States · Issued August 24, 2017

Overview

  • 14 public-safe observations are available for this inspection.
  • 12 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.

24 Aug 2017
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Aqualia L Nelson

24 Aug 2017
21 CFR 110.10(c)

Level of competency (S)

Cited by Aqualia L Nelson

24 Aug 2017
21 CFR 110.20(a)(1)

Harborage areas

Cited by Aqualia L Nelson

24 Aug 2017
21 CFR 110.20(b)(7)

Screening

Cited by Aqualia L Nelson

24 Aug 2017
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Aqualia L Nelson

Inspected site

MBMarquez Bakery of Odessa, IncOdessa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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