Form 483

Sumbaker GP Form 483, 2019-10-31

FDA issued a Form 483 to Sumbaker GP on 2019-10-31 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Sumbaker GP · Memphis, United States · Issued October 31, 2019

Overview

  • 8 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.

31 Oct 2019
21 CFR 117.20(a)

Grounds

Cited by Richard L Garcia, Anetra E Wyatt

31 Oct 2019
21 CFR 117.20(b)

Plant Construction and Design

Cited by Richard L Garcia, Anetra E Wyatt

31 Oct 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Richard L Garcia, Anetra E Wyatt

31 Oct 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Richard L Garcia, Anetra E Wyatt

31 Oct 2019
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Richard L Garcia, Anetra E Wyatt

Inspected site

SGSumbaker GPMemphis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.20(a)Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x
21 CFR 117.35(e)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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