Medtronic Heart Valves Division
FDA inspection history in Santa Ana, California, 2016 to 2020
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Santa Ana, California.
- 2020One Form 483, at Santa Ana, California.
- 2020The longest 483 on file: 2 observations over 7 pages at Santa Ana, California.
Cited most
Across all Medtronic Heart Valves Division observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.70(a)Production and process controls1
The complete Medtronic Heart Valves Division file.
All 2 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
Santa Ana, California
Two Form 483s · 2016 to 2020 · 4 observations
Latest: Form 483, Oct 26, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-10-26 | 483 Form 483 | Santa Ana, California | 2 | $99 |
| 2016-03-30 | 483 Form 483 | Santa Ana, California | 2 | $99 |
Investigators on these documents
FEI number 2025587 · most recent document Oct 26, 2020
About Medtronic Heart Valves Division
How many FDA Form 483s has Medtronic Heart Valves Division received?
FDA Intel has 2 Form 483s on file for Medtronic Heart Valves Division; the most recent is dated Oct 26, 2020.
When was Medtronic Heart Valves Division last inspected by FDA?
The most recent FDA inspection document on file for Medtronic Heart Valves Division is a Form 483 dated Oct 26, 2020, for the site in Santa Ana, California.
What did FDA cite at Medtronic Heart Valves Division?
The regulations cited most in the observations on file for Medtronic Heart Valves Division are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time; 21 CFR 820.70(a) (Production and process controls), 1 time.