Form 483

SYSCO Detroit, LLC Form 483, 2013-01-11

FDA issued a Form 483 to SYSCO Detroit, LLC on 2013-01-11 with 4 public-safe observations.

483· Form 483 issued4 observations

SYSCO Detroit, LLC · Canton, United States · Issued January 11, 2013

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.

11 Jan 2013
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Lauren E Burke

11 Jan 2013
21 CFR 123.6(c)(7)

Records system

Cited by Lauren E Burke

11 Jan 2013
21 CFR 123.8(a)(3)(i)

Monitoring record review adequacy

Cited by Lauren E Burke

11 Jan 2013
21 CFR 123.12(a)(2)

Importer verification

Cited by Lauren E Burke

Inspected site

SDSYSCO Detroit, LLCCanton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)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