Delcath Systems, Inc.
Form 483 issued June 9, 2023 · Queensbury, New York
- Inspection
- May 30 – Jun 9, 2023
- Investigator
- Jacqueline S. Warner
- Observations
- 3
- Pages
- 4
- FEI number
- 3008822486
In short: On June 9, 2023, FDA issued a Form 483 with 3 observations to Delcath Systems, Inc. in Queensbury, New York (FEI 3008822486) after an inspection that ran May 30 – Jun 9, 2023. The investigator was Jacqueline S. Warner. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Corrective and preventive action activities and/or results have…
- 03
Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and…
This inspection in context
Jacqueline S. Warner
7 documents · 2008–2024
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 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delcath Systems, Inc.?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Delcath Systems, Inc.?
Jacqueline S. Warner is named on this Form 483, for the inspection of May 30 – Jun 9, 2023. Each investigator has a profile showing what they cite most.
When was Delcath Systems, Inc. inspected by FDA?
The inspection ran May 30 – Jun 9, 2023, and the Form 483 is dated June 9, 2023.
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.