Medtronic, Inc.
FDA inspection history in Minneapolis, Minnesota, 2012 to 2019
- 10
- Responses
- 3
- Form 483s
- 2
- Close-outs
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Response
- Warning letter
2012: four warning letter responses, two 483 responses, one warning letter and one Form 483; 2013: two warning letter responses, one 483 response and one Form 483; 2014: one warning letter response; 2015: one close-out letter; 2017: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–19Seven warning letter responses, three 483 responses, three Form 483s, two close-out letters and one warning letter, at Minneapolis, Minnesota.
- 2012The longest 483 on file: 6 observations over 10 pages at Minneapolis, Minnesota.
Cited most
Across all Medtronic observations on file
- 21 CFR 820.100Corrective and preventive action3
- 21 CFR 820.198Complaint files3
- 21 CFR 820.30(c)Design controls2
- 21 CFR 211.198Complaint files1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Medtronic file.
All 16 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Minneapolis, Minnesota
Seven warning letter responses, three Form 483s, three 483 responses, two close-out letters and one warning letter · 2012 to 2019 · 11 observations
Latest: Form 483, Oct 17, 2019 →
Documents
16 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-17 | 483 Form 483 | Minneapolis, Minnesota | 2 | $99 |
| 2017-11-02 | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
| 2015-02-02 | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
| 2014-01-15 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2013-07-15 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2013-04-24 | Response 483 response | Minneapolis, Minnesota | — | $199 |
| 2013-04-03 | 483 Form 483 | Minneapolis, Minnesota | 3 | $99 |
| 2013-01-17 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2012-12-07 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2012-10-12 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2012-08-29 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2012-08-09 | Response Warning letter response | Minneapolis, Minnesota | — | $199 |
| 2012-07-17 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
| 2012-06-29 | Response 483 response | Minneapolis, Minnesota | — | $199 |
| 2012-05-30 | Response 483 response | Minneapolis, Minnesota | — | $199 |
| 2012-05-09 | 483 Form 483 | Minneapolis, Minnesota | 6 | $99 |
Investigators on these documents
April L. Brown (8)Marissa S. Henning (8)Susan M. Matthias (3)Jessica L. Johnson (2)Joseph D. Gong (1)Ryan J. Benedict (1)
FEI number 2182207 · most recent document Oct 17, 2019
About Medtronic, Inc.
How many FDA Form 483s has Medtronic, Inc. received?
FDA Intel has 3 Form 483s on file for Medtronic, Inc.; the most recent is dated Oct 17, 2019.
When was Medtronic, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Medtronic, Inc. is a Form 483 dated Oct 17, 2019, for the site in Minneapolis, Minnesota.
What did FDA cite at Medtronic, Inc.?
The regulations cited most in the observations on file for Medtronic, Inc. are 21 CFR 820.100 (Corrective and preventive action), 3 times; 21 CFR 820.198 (Complaint files), 3 times; 21 CFR 820.30(c) (Design controls), 2 times.
Has Medtronic, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medtronic, Inc.; the most recent is dated Jul 17, 2012.