Atlas

Form 483

Medtronic CryoCath LP Form 483, 2016-10-27

FDA issued a Form 483 to Medtronic CryoCath LP on 2016-10-27 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Medtronic CryoCath LP · Montreal, Canada · Issued October 27, 2016

Overview

  • 6 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.

27 Oct 2016
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Catherine J Laufmann

27 Oct 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Catherine J Laufmann

27 Oct 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Catherine J Laufmann

27 Oct 2016
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Catherine J Laufmann

27 Oct 2016
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Catherine J Laufmann

Inspected site

MCMedtronic CryoCath LPMontreal, Canada

Inspection team

CJCatherine J Laufmann

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(3)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 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