Xodus Medical Inc

FDA inspection history in New Kensington, Pennsylvania, 2019

1
Form 483

Every document, by year

  • Form 483

2019: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at New Kensington, Pennsylvania.

Cited most

Across all Xodus Medical observations on file

The complete Xodus Medical 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
2019-08-14483 Form 483$99

Investigators on these documents

Dennis R. Hock (1)

FEI number 1000221205 · most recent document Aug 14, 2019

About Xodus Medical Inc

How many FDA Form 483s has Xodus Medical Inc received?

FDA Intel has 1 Form 483 on file for Xodus Medical Inc; the most recent is dated Aug 14, 2019.

When was Xodus Medical Inc last inspected by FDA?

The most recent FDA inspection document on file for Xodus Medical Inc is a Form 483 dated Aug 14, 2019, for the site in New Kensington, Pennsylvania.

What did FDA cite at Xodus Medical Inc?

The regulations cited most in the observations on file for Xodus Medical Inc are 21 CFR 820.198(c) (Complaint files), 1 time; 21 CFR 820.75(c) (Process validation), 1 time.