Medtronic Heart Valves Division
Form 483 issued October 26, 2020 · Santa Ana, California
- Inspection
- Oct 13 – Oct 26, 2020
- Investigator
- Kirtida Patel
- Observations
- 2
- Pages
- 7
- FEI number
- 2025587
In short: On October 26, 2020, FDA issued a Form 483 with 2 observations to Medtronic Heart Valves Division in Santa Ana, California (FEI 2025587) after an inspection that ran Oct 13 – Oct 26, 2020. The investigator was Kirtida Patel. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(c) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Kirtida Patel
4 documents · 2008–2020
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmMedtronic Heart Valves Division history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic Heart Valves Division?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Medtronic Heart Valves Division?
Kirtida Patel is named on this Form 483, for the inspection of Oct 13 – Oct 26, 2020. Each investigator has a profile showing what they cite most.
When was Medtronic Heart Valves Division inspected by FDA?
The inspection ran Oct 13 – Oct 26, 2020, and the Form 483 is dated October 26, 2020.
How do I get the full Form 483 for Medtronic Heart Valves Division?
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.