Atlas

Form 483

Sumbaker GP Form 483, 2012-02-15

FDA issued a Form 483 to Sumbaker GP on 2012-02-15 with 4 public-safe observations.

483· Form 483 issued4 observations

Sumbaker GP · Memphis, United States · Issued February 15, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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 Feb 2012
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Erica L Sullivan

15 Feb 2012
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Erica L Sullivan

15 Feb 2012
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Erica L Sullivan

15 Feb 2012
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Erica L Sullivan

Inspected site

SGSumbaker GPMemphis, United States

Inspection team

ELErica L Sullivan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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