Atlas

Form 483

Shaklee Corporation Form 483, 2009-12-31

FDA issued a Form 483 to Shaklee Corporation on 2009-12-31 with 6 public-safe observations.

483· Form 483 issued6 observations

Shaklee Corporation · Groveport, United States · Issued December 31, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

31 Dec 2009
21 CFR 211.22(a)

Approve or reject components, products

Cited by Michael E Clark

31 Dec 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Michael E Clark

31 Dec 2009
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Michael E Clark

31 Dec 2009
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Michael E Clark

31 Dec 2009
21 CFR 211.166(a)

Lack of written stability program

Cited by Michael E Clark

Inspected site

SCShaklee CorporationGroveport, United States

Inspection team

MEMichael E Clark

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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