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Form 483

J and L Grocery, LLC Form 483, 2018-10-23

FDA issued a Form 483 to J and L Grocery, LLC on 2018-10-23 with 33 public-safe observations.

483· Form 483 issuedFoods & Cosmetics33 observations

J and L Grocery, LLC · Alma, United States · Issued October 23, 2018

Overview

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

Inspectional observations

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

23 Oct 2018
21 CFR 117.20(a)

Grounds

Cited by Danielle Lyke, Hung V Le, Brandi E Williams, Ed Gonzalez Vazquez, James R Montero, Aqualia L Nelson, Michael L Jones, Constance M Dobbins, Shelby N Marler

23 Oct 2018
21 CFR 117.20(a)

Grounds

Cited by Danielle Lyke, Hung V Le, Brandi E Williams, Ed Gonzalez Vazquez, James R Montero, Aqualia L Nelson, Michael L Jones, Constance M Dobbins, Shelby N Marler

23 Oct 2018
21 CFR 117.20(a)

Grounds

Cited by Danielle Lyke, Hung V Le, Brandi E Williams, Ed Gonzalez Vazquez, James R Montero, Aqualia L Nelson, Michael L Jones, Constance M Dobbins, Shelby N Marler

23 Oct 2018
21 CFR 117.20(b)

Plant Construction and Design

Cited by Danielle Lyke, Hung V Le, Brandi E Williams, Ed Gonzalez Vazquez, James R Montero, Aqualia L Nelson, Michael L Jones, Constance M Dobbins, Shelby N Marler

23 Oct 2018
21 CFR 117.20(b)

Plant Construction and Design

Cited by Danielle Lyke, Hung V Le, Brandi E Williams, Ed Gonzalez Vazquez, James R Montero, Aqualia L Nelson, Michael L Jones, Constance M Dobbins, Shelby N Marler

Inspected site

JAJ and L Grocery, LLCAlma, United States

Inspection team

DLDanielle Lyke
HVHung V Le
BEBrandi E Williams
EGEd Gonzalez Vazquez
JRJames R Montero
ALAqualia L Nelson
MLMichael L Jones
CMConstance M Dobbins
SNShelby N Marler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.208Cited across public-safe Form 483 observations6x
21 CFR 117.20(a)Cited across public-safe Form 483 observations3x
21 CFR 117.20(b)Cited across public-safe Form 483 observations3x
21 CFR 117.35(c)Cited across public-safe Form 483 observations3x
21 CFR 117.80(a)Cited across public-safe Form 483 observations3x
21 CFR 211.142(b)Cited across public-safe Form 483 observations3x
21 CFR 211.42(b)Cited across public-safe Form 483 observations3x
21 CFR 211.46(b)Cited across public-safe Form 483 observations3x
21 CFR 211.56(a)Cited across public-safe Form 483 observations3x
21 CFR 211.58Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 33 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