Medtronic, Inc.
Form 483 issued January 21, 2011 · Minneapolis, Minnesota
- Inspection
- Nov 17, 2010 – Jan 21, 2011
- Investigators
- Jessica L. Johnson· Susan M. Atcher
- Observations
- 5
- Pages
- 8
- FEI number
- 3007566237
In short: On January 21, 2011, FDA issued a Form 483 with 5 observations to Medtronic, Inc. in Minneapolis, Minnesota (FEI 3007566237) after an inspection that ran Nov 17, 2010 – Jan 21, 2011. The investigators were Jessica L. Johnson and Susan M. Atcher. 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 4 of 5 observations.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
The design was not validated using initial production units, lots or…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Corrective and preventive action activities and/or results have…
This inspection in context
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 firmMedtronic, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic, Inc.?
FDA listed 5 observations on this Form 483, mostly about design controls, cAPA and production & process controls. 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.?
Jessica L. Johnson and Susan M. Atcher are named on this Form 483, for the inspection of Nov 17, 2010 – Jan 21, 2011. Each investigator has a profile showing what they cite most.
When was Medtronic, Inc. inspected by FDA?
The inspection ran Nov 17, 2010 – Jan 21, 2011, and the Form 483 is dated January 21, 2011.
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.