Atlas

Form 483

Klarity Medical Products LLC Form 483, 2013-09-30

FDA issued a Form 483 to Klarity Medical Products LLC on 2013-09-30 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Klarity Medical Products LLC · Heath, United States · Issued September 30, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

30 Sep 2013
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Rosanna M Goodrich

30 Sep 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Rosanna M Goodrich

Inspected site

KMKlarity Medical Products LLCHeath, United States

Inspection team

RMRosanna M Goodrich

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x

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