Medtronic MiniMed, Inc.
Form 483 issued March 24, 2017 · Northridge, California
- Inspection
- Mar 7 – Mar 24, 2017
- Investigator
- Janet Pulver
- Observations
- 3
- Pages
- 7
- FEI number
- 3003166194
In short: On March 24, 2017, FDA issued a Form 483 with 3 observations to Medtronic MiniMed, Inc. in Northridge, California (FEI 3003166194) after an inspection that ran Mar 7 – Mar 24, 2017. The investigator was Janet Pulver. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance of incoming product have…
- 02
Products that do not conform to specifications…
- 03
Procedures for the control of storage areas and stock rooms have…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmMedtronic MiniMed, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic MiniMed, Inc.?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Medtronic MiniMed, Inc.?
Janet Pulver is named on this Form 483, for the inspection of Mar 7 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was Medtronic MiniMed, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
How do I get the full Form 483 for Medtronic MiniMed, 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.