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Form 483

Medtronic Navigation, Inc. Form 483, 2019-09-30

FDA issued a Form 483 to Medtronic Navigation, Inc. on 2019-09-30 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Medtronic Navigation, Inc. · Lafayette, United States · Issued September 30, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 2019
21 CFR 1040.10(i)

Certified product modification

Cited by Matthew M Vernon

Inspected site

MNMedtronic Navigation, Inc.Lafayette, United States

Inspection team

MMMatthew M Vernon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1040.10(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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