Atlas

Form 483

Cadwell Industries, Inc. Form 483, 2013-04-30

FDA issued a Form 483 to Cadwell Industries, Inc. on 2013-04-30 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Cadwell Industries, Inc. · Kennewick, United States · Issued April 30, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Apr 2013
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Paul M Kawamoto

30 Apr 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Paul M Kawamoto

30 Apr 2013
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Paul M Kawamoto

Inspected site

CICadwell Industries, Inc.Kennewick, United States

Inspection team

PMPaul M Kawamoto

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited 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