Medtronic MiniMed, Inc.
FDA inspection history across 2 sites, 2013 to 2021
- 2
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2013: one warning letter; 2017: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Northridge, California.
- 2017One Form 483, at Northridge, California.
- 2021One warning letter, at Minneapolis, Minnesota.
Cited most
Across all Medtronic MiniMed observations on file
- 21 CFR 820.150Storage1
- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90(a)Nonconforming product1
The complete Medtronic MiniMed file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Minneapolis, Minnesota
One warning letter and one close-out letter · 2021
Latest: Warning letter, Dec 9, 2021 →Northridge, California
One Form 483 and one warning letter · 2013 to 2017 · 3 observations
Latest: Form 483, Mar 24, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-09 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
| 2017-03-24 | 483 Form 483 | Northridge, California | 3 | $99 |
| 2013-09-19 | Warning letter Warning letter | Northridge, California | — | $99 |
| Undated | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
Investigators on these documents
FEI number 3003166194 · most recent document Dec 9, 2021
About Medtronic MiniMed, Inc.
How many FDA Form 483s has Medtronic MiniMed, Inc. received?
FDA Intel has 1 Form 483 on file for Medtronic MiniMed, Inc.; the most recent is dated Mar 24, 2017.
When was Medtronic MiniMed, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Medtronic MiniMed, Inc. is a Form 483 dated Mar 24, 2017, for the site in Northridge, California.
What did FDA cite at Medtronic MiniMed, Inc.?
The regulations cited most in the observations on file for Medtronic MiniMed, Inc. are 21 CFR 820.150 (Storage), 1 time; 21 CFR 820.80(b) (Receiving, in-process, and finished device acceptance), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.
Has Medtronic MiniMed, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Medtronic MiniMed, Inc.; the most recent is dated Dec 9, 2021.