Medtronic Heart Valves Division
Form 483 issued March 30, 2016 · Santa Ana, California
- Inspection
- Mar 15 – Mar 30, 2016
- Investigator
- Kirtida Patel
- Observations
- 2
- Pages
- 2
- FEI number
- 2025587
In short: On March 30, 2016, FDA issued a Form 483 with 2 observations to Medtronic Heart Valves Division in Santa Ana, California (FEI 2025587) after an inspection that ran Mar 15 – Mar 30, 2016. The investigator was Kirtida Patel. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Observations span 1 system, led by production & process controls.
Most cited: 21 CFR 820.70(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 02
: Not…
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 820.70(a)
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 production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). 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 Mar 15 – Mar 30, 2016. Each investigator has a profile showing what they cite most.
When was Medtronic Heart Valves Division inspected by FDA?
The inspection ran Mar 15 – Mar 30, 2016, and the Form 483 is dated March 30, 2016.
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.