Atlas

Form 483

Etai's Food, LLC. Form 483, 2019-01-30

FDA issued a Form 483 to Etai's Food, LLC. on 2019-01-30 with 27 public-safe observations.

483· Form 483 issuedFoods & Cosmetics27 observations

Etai's Food, LLC. · Denver, United States · Issued January 30, 2019

Overview

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

Inspectional observations

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

30 Jan 2019
21 CFR 117.10

Personnel

Cited by Sheila Alaghemand, Carrie E Jolly, Brandon K Lawson, Laura L Van Wagenen, Oluwaseyi Ojinni

30 Jan 2019
21 CFR 117.10

Personnel

Cited by Sheila Alaghemand, Carrie E Jolly, Brandon K Lawson, Laura L Van Wagenen, Oluwaseyi Ojinni

30 Jan 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Sheila Alaghemand, Carrie E Jolly, Brandon K Lawson, Laura L Van Wagenen, Oluwaseyi Ojinni

30 Jan 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Sheila Alaghemand, Carrie E Jolly, Brandon K Lawson, Laura L Van Wagenen, Oluwaseyi Ojinni

30 Jan 2019
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Sheila Alaghemand, Carrie E Jolly, Brandon K Lawson, Laura L Van Wagenen, Oluwaseyi Ojinni

Inspected site

EFEtai's Food, LLC.Denver, United States

Inspection team

SASheila Alaghemand
CECarrie E Jolly
BKBrandon K Lawson
LLLaura L Van Wagenen
OOOluwaseyi Ojinni

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations6x
21 CFR 117.10Cited across public-safe Form 483 observations3x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.145(b)Cited across public-safe Form 483 observations3x
21 CFR 117.150(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 123.6(b)Cited across public-safe Form 483 observations3x
21 CFR 123.8(b)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 27 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