Company
United StatesPublic company, NASDAQ: DCTHDelcath Systems Inc. (NASDAQ: DCTH), Queensbury, NY – FDA Inspections
Inspection records and compliance data for Delcath Systems Inc. in Queensbury, New York. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 11, 2026. Publicly traded as NASDAQ: DCTH.
Company Profile
This profile covers Delcath Systems Inc. based in Queensbury, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 15, 2013. Last inspected September 11, 2026.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Documentation1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2026 | Not classified | Human Drugs | 1336276 |
| April 9, 2025 | Not classified | Human Drugs | 1268099 |
| June 9, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1207785 |
| November 9, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 991770 |
| February 15, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 816828 |
FDA documents
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Delcath Systems Inc.
Stock ticker
DCTH
Exchange
NASDAQ
Share price
$21.38
Market cap
$743.8M
Price as of
November 13, 2026
FEI Number
3008822486
Address
566 Queensbury Ave, Queensbury, New York 12804, United States
Country
United States
ID: ce3ea8cb-f842-43a9-9eb4-91e58e74932b