Atlas

Form 483

CareFusion 303, Inc. Form 483, 2012-12-18

FDA issued a Form 483 to CareFusion 303, Inc. on 2012-12-18 with 3 public-safe observations.

483· Form 483 issued3 observations

CareFusion 303, Inc. · San Diego, United States · Issued December 18, 2012

Overview

  • 3 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.

18 Dec 2012
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Scott K Zika

18 Dec 2012
21 CFR 820.30(g)

Design validation- Lack of or inadequate procedures

Cited by Scott K Zika

18 Dec 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Scott K Zika

Inspected site

C3CareFusion 303, Inc.San Diego, United States

Inspection team

SKScott K Zika

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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