Medtronic, Inc.
Form 483 issued October 17, 2019 · Minneapolis, Minnesota
- Inspection
- Sep 19 – Oct 17, 2019
- Investigators
- Joseph D. Gong· Susan M. Matthias
- Observations
- 2
- Pages
- 5
- FEI number
- 2182207
In short: On October 17, 2019, FDA issued a Form 483 with 2 observations to Medtronic, Inc. in Minneapolis, Minnesota (FEI 2182207) after an inspection that ran Sep 19 – Oct 17, 2019. The investigators were Joseph D. Gong and Susan M. Matthias. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.30(c) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Design input requirements were…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Joseph D. Gong
4 documents · 2017–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmMedtronic, Inc. history
All 16 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic, Inc.?
FDA listed 2 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Medtronic, Inc.?
Joseph D. Gong and Susan M. Matthias are named on this Form 483, for the inspection of Sep 19 – Oct 17, 2019. Each investigator has a profile showing what they cite most.
When was Medtronic, Inc. inspected by FDA?
The inspection ran Sep 19 – Oct 17, 2019, and the Form 483 is dated October 17, 2019.
How do I get the full Form 483 for Medtronic, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.