Form 483

Mi Tierra Food, LLC Form 483, 2022-09-15

FDA issued a Form 483 to Mi Tierra Food, LLC on 2022-09-15 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Mi Tierra Food, LLC · Newark, United States · Issued September 15, 2022

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

15 Sep 2022
21 CFR 1.504(a)

Hazard analysis written

Cited by Ayorinde O Babalola

15 Sep 2022
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Ayorinde O Babalola

15 Sep 2022
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Ayorinde O Babalola

15 Sep 2022
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Ayorinde O Babalola

15 Sep 2022
21 CFR 1.510(a)(2)

Record - sign, date

Cited by Ayorinde O Babalola

Inspected site

MTMi Tierra Food, LLCNewark, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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