Form 483

Alimentos Naturales Sabroza Form 483, 2018-07-27

FDA issued a Form 483 to Alimentos Naturales Sabroza on 2018-07-27 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Alimentos Naturales Sabroza · Guadalupe, Mexico · Issued July 27, 2018

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Jul 2018
21 CFR 114.10

Personnel

Cited by Thomas Siebertz, Asha Dwarka

27 Jul 2018
21 CFR 114.80(a)(1)

Scheduled process

Cited by Thomas Siebertz, Asha Dwarka

27 Jul 2018
21 CFR 114.80(a)(2)

pH testing

Cited by Thomas Siebertz, Asha Dwarka

27 Jul 2018
21 CFR 114.83

Scheduled process establishment

Cited by Thomas Siebertz, Asha Dwarka

27 Jul 2018
21 CFR 114.89

Process deviation evaluation

Cited by Thomas Siebertz, Asha Dwarka

Inspected site

ANAlimentos Naturales SabrozaGuadalupe, Mexico

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.10Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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