Form 483

Kimberly-Clark Corporation Form 483, 2019-07-25

FDA issued a Form 483 to Kimberly-Clark Corporation on 2019-07-25 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Kimberly-Clark Corporation · Neenah, United States · Issued July 25, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

25 Jul 2019
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Jennifer S Ness, Mary K Concannon, Nicholas T Domer

25 Jul 2019
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Jennifer S Ness, Mary K Concannon, Nicholas T Domer

Inspected site

KCKimberly-Clark CorporationNeenah, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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