Medtronic Puerto Rico Operations Company
FDA inspection history across 2 sites, 2009 to 2020
- 3
- Form 483s
- 2
- Close-outs
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2009: one warning letter; 2010: one Form 483; 2016: one Form 483; 2018: one close-out letter; 2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–10One warning letter and one Form 483, at Minneapolis, Minnesota and Juncos, Puerto Rico.
- 2010The longest 483 on file: 6 observations over 7 pages at Juncos, Puerto Rico.
- 2016–20Two Form 483s and two close-out letters, at Juncos, Puerto Rico and Minneapolis, Minnesota.
Cited most
Across all Medtronic Puerto Rico Operations observations on file
- 21 CFR 820.198Complaint files4
- 21 CFR 820.100Corrective and preventive action3
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.75Process validation1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
The complete Medtronic Puerto Rico Operations file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Minneapolis, Minnesota
Two close-out letters and one warning letter · 2009 to 2020
Latest: Close-out, Feb 20, 2020 →Juncos, Puerto Rico
Three Form 483s · 2010 to 2019 · 10 observations
Latest: Form 483, Oct 25, 2019 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-20 | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
| 2019-10-25 | 483 Form 483 | Juncos, Puerto Rico | 1 | $99 |
| 2018-08-23 | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
| 2016-04-28 | 483 Form 483 | Juncos, Puerto Rico | 3 | $99 |
| 2010-03-10 | 483 Form 483 | Juncos, Puerto Rico | 6 | $99 |
| 2009-06-01 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
Investigators on these documents
Laiza V. Garcia (2)Dianiris C. Ayala (1)Gonzalez Pizarro (1)Marilyn Santiago (1)Monica C. Burgos Garcia (1)
FEI number 3004369318 · most recent document Feb 20, 2020
About Medtronic Puerto Rico Operations Company
How many FDA Form 483s has Medtronic Puerto Rico Operations Company received?
FDA Intel has 3 Form 483s on file for Medtronic Puerto Rico Operations Company; the most recent is dated Oct 25, 2019.
When was Medtronic Puerto Rico Operations Company last inspected by FDA?
The most recent FDA inspection document on file for Medtronic Puerto Rico Operations Company is a Form 483 dated Oct 25, 2019, for the site in Juncos, Puerto Rico.
What did FDA cite at Medtronic Puerto Rico Operations Company?
The regulations cited most in the observations on file for Medtronic Puerto Rico Operations Company are 21 CFR 820.198 (Complaint files), 4 times; 21 CFR 820.100 (Corrective and preventive action), 3 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time.
Has Medtronic Puerto Rico Operations Company received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medtronic Puerto Rico Operations Company; the most recent is dated Jun 1, 2009.