Medtronic, Inc.
Form 483 issued May 9, 2012 · Minneapolis, Minnesota
- Inspection
- Mar 14 – May 9, 2012
- Investigators
- April L. Brown· Marissa S. Henning· Ryan J. Benedict
- Observations
- 6
- Pages
- 10
- FEI number
- 2182207
In short: On May 9, 2012, FDA issued a Form 483 with 6 observations to Medtronic, Inc. in Minneapolis, Minnesota (FEI 2182207) after an inspection that ran Mar 14 – May 9, 2012. The investigators were April L. Brown, Marissa S. Henning and Ryan J. Benedict. Most observations concern cAPA and materials; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
4 of 6 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated…
This inspection in context
April L. Brown
8 documents · 2012–2013
Cites 820.198 (complaint files) 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 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic, Inc.?
FDA listed 6 observations on this Form 483, mostly about cAPA, materials and quality system. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Medtronic, Inc.?
April L. Brown, Marissa S. Henning and Ryan J. Benedict are named on this Form 483, for the inspection of Mar 14 – May 9, 2012. Each investigator has a profile showing what they cite most.
When was Medtronic, Inc. inspected by FDA?
The inspection ran Mar 14 – May 9, 2012, and the Form 483 is dated May 9, 2012.
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.