Atlas

Form 483

Physio-Control, Inc. Form 483, 2014-01-17

FDA issued a Form 483 to Physio-Control, Inc. on 2014-01-17 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Physio-Control, Inc. · Redmond, United States · Issued January 17, 2014

Overview

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

Inspectional observations

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

17 Jan 2014
21 CFR 820.30(f)

Design verification - output does not meet input requirement

Cited by Paul M Kawamoto, Cynthia L Gorveatt

17 Jan 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Paul M Kawamoto, Cynthia L Gorveatt

17 Jan 2014
21 CFR 821.25(c)(3)

Quality assurance procedures: 6-month & annual audits

Cited by Paul M Kawamoto, Cynthia L Gorveatt

Inspected site

PIPhysio-Control, Inc.Redmond, United States

Inspection team

PMPaul M Kawamoto
CLCynthia L Gorveatt

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 820.30(f)Cited across public-safe Form 483 observations1x
21 CFR 821.25(c)(3)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