Xodus Medical Inc
Form 483 issued August 14, 2019 · New Kensington, Pennsylvania
- Inspection
- Jul 23 – Aug 14, 2019
- Investigator
- Dennis R. Hock
- Observations
- 2
- Pages
- 6
- FEI number
- 1000221205
In short: On August 14, 2019, FDA issued a Form 483 with 2 observations to Xodus Medical Inc in New Kensington, Pennsylvania (FEI 1000221205) after an inspection that ran Jul 23 – Aug 14, 2019. The investigator was Dennis R. Hock. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75(c) (1×) · 820.198(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A validated process was not reviewed and evaluated and revalidated when changes…
- 02
Complaints involving the possible failure of a device, labeling and packaging to meet any of its…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmXodus Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xodus Medical Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Xodus Medical Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Jul 23 – Aug 14, 2019. Each investigator has a profile showing what they cite most.
When was Xodus Medical Inc inspected by FDA?
The inspection ran Jul 23 – Aug 14, 2019, and the Form 483 is dated August 14, 2019.
How do I get the full Form 483 for Xodus Medical 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.