FDA Intel

Medtronic, Inc.

Form 483 issued April 3, 2013 · Minneapolis, Minnesota

Inspection
Feb 14 – Apr 3, 2013
Investigators
Jessica L. Johnson· Susan M. Matthias
Observations
3
Pages
6
FEI number
2182207

In short: On April 3, 2013, FDA issued a Form 483 with 3 observations to Medtronic, Inc. in Minneapolis, Minnesota (FEI 2182207) after an inspection that ran Feb 14 – Apr 3, 2013. The investigators were Jessica L. Johnson and Susan M. Matthias. Most observations concern cAPA and design controls.

At a glance

2 of 3 observations on this 483 concern capa.

CAPA2
Design controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.90(a)

    Products that do not conform to specifications…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  3. 03
    21 CFR 820.30(f)

    Design verification does not confirm that design output…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Jessica L. Johnson

7 documents · 2011–2013

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Minnesota.

The firm

Medtronic, Inc. history

All 16 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.90(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Medtronic, Inc.?

FDA listed 3 observations on this Form 483, mostly about cAPA and design controls. The opening words of each observation are shown on this page.

Who inspected Medtronic, Inc.?

Jessica L. Johnson and Susan M. Matthias are named on this Form 483, for the inspection of Feb 14 – Apr 3, 2013. Each investigator has a profile showing what they cite most.

When was Medtronic, Inc. inspected by FDA?

The inspection ran Feb 14 – Apr 3, 2013, and the Form 483 is dated April 3, 2013.

How do I get the full Form 483 for Medtronic, Inc.?

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