Atlas

Form 483

Medtronic MiniMed, Inc. Form 483, 2023-03-10

FDA issued a Form 483 to Medtronic MiniMed, Inc. on 2023-03-10 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Medtronic MiniMed, Inc. · Northridge, United States · Issued March 10, 2023

Overview

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

Inspectional observations

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

10 Mar 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan

10 Mar 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan

10 Mar 2023
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan

Inspected site

MMMedtronic MiniMed, Inc.Northridge, United States

Inspection team

SRStephen R Souza
MMMatthew M Vernon
EAElizabeth A Dakan

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 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 3 observations

The source PDF, 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