Delcath Systems, Inc.
Form 483 issued February 15, 2013 · Queensbury, New York
- Inspection
- Jan 22 – Feb 15, 2013
- Investigators
- Catherine M. Beer· Chad N. Thompson
- Observations
- 7
- Pages
- 4
- FEI number
- 3008822486
In short: On February 15, 2013, FDA issued a Form 483 with 7 observations to Delcath Systems, Inc. in Queensbury, New York (FEI 3008822486) after an inspection that ran Jan 22 – Feb 15, 2013. The investigators were Catherine M. Beer and Chad N. Thompson. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 6 of 7 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
Design input requirements were…
- 02
Design validation did not ensure the device conforms to defined user…
- 03
Design verification does not confirm that design output…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Catherine M. Beer
1 document · 2013
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New York.
The firmDelcath Systems, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delcath Systems, Inc.?
FDA listed 7 observations on this Form 483, mostly about design controls, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Delcath Systems, Inc.?
Catherine M. Beer and Chad N. Thompson are named on this Form 483, for the inspection of Jan 22 – Feb 15, 2013. Each investigator has a profile showing what they cite most.
When was Delcath Systems, Inc. inspected by FDA?
The inspection ran Jan 22 – Feb 15, 2013, and the Form 483 is dated February 15, 2013.
How do I get the full Form 483 for Delcath Systems, 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.