Medtronic Xomed, Inc
Form 483 issued March 16, 2016 · Jacksonville, Florida
- Inspection
- Mar 7 – Mar 16, 2016
- Investigator
- Richard K. Vogel
- Observations
- 6
- Pages
- 7
- FEI number
- 1045254
In short: On March 16, 2016, FDA issued a Form 483 with 6 observations to Medtronic Xomed, Inc in Jacksonville, Florida (FEI 1045254) after an inspection that ran Mar 7 – Mar 16, 2016. The investigator was Richard K. Vogel. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 5 of 6 observations.
Most cited: 21 CFR 820.30 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design validation have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures for design input…
This inspection in context
Richard K. Vogel
4 documents · 2010–2018
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmMedtronic Xomed, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic Xomed, Inc?
FDA listed 6 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Medtronic Xomed, Inc?
Richard K. Vogel is named on this Form 483, for the inspection of Mar 7 – Mar 16, 2016. Each investigator has a profile showing what they cite most.
When was Medtronic Xomed, Inc inspected by FDA?
The inspection ran Mar 7 – Mar 16, 2016, and the Form 483 is dated March 16, 2016.
How do I get the full Form 483 for Medtronic Xomed, Inc?
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.