Medtronic Xomed, Inc

FDA inspection history in Jacksonville, Florida, 2016

1
Form 483

Every document, by year

  • Form 483

2016: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2016One Form 483, at Jacksonville, Florida.

Cited most

Across all Medtronic Xomed observations on file

The complete Medtronic Xomed file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2016-03-16483 Form 483$99

Investigators on these documents

Richard K. Vogel (1)

FEI number 1045254 · most recent document Mar 16, 2016

About Medtronic Xomed, Inc

How many FDA Form 483s has Medtronic Xomed, Inc received?

FDA Intel has 1 Form 483 on file for Medtronic Xomed, Inc; the most recent is dated Mar 16, 2016.

When was Medtronic Xomed, Inc last inspected by FDA?

The most recent FDA inspection document on file for Medtronic Xomed, Inc is a Form 483 dated Mar 16, 2016, for the site in Jacksonville, Florida.

What did FDA cite at Medtronic Xomed, Inc?

The regulations cited most in the observations on file for Medtronic Xomed, Inc are 21 CFR 820.30 (Design controls), 3 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.198 (Complaint files), 1 time.