Delcath Systems, Inc.
FDA inspection history in Queensbury, New York, 2013 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Queensbury, New York.
- 2013The longest 483 on file: 7 observations over 4 pages at Queensbury, New York.
- 2023One Form 483, at Queensbury, New York.
Cited most
Across all Delcath Systems observations on file
- 21 CFR 820.30Design controls3
- 21 CFR 820.50Purchasing controls2
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.181Device master record1
The complete Delcath Systems file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Queensbury, New York
Two Form 483s · 2013 to 2023 · 10 observations
Latest: Form 483, Jun 9, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-09 | 483 Form 483 | Queensbury, New York | 3 | $99 |
| 2013-02-15 | 483 Form 483 | Queensbury, New York | 7 | $99 |
Investigators on these documents
Catherine M. Beer (1)Chad N. Thompson (1)Jacqueline S. Warner (1)
FEI number 3008822486 · most recent document Jun 9, 2023
About Delcath Systems, Inc.
How many FDA Form 483s has Delcath Systems, Inc. received?
FDA Intel has 2 Form 483s on file for Delcath Systems, Inc.; the most recent is dated Jun 9, 2023.
When was Delcath Systems, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Delcath Systems, Inc. is a Form 483 dated Jun 9, 2023, for the site in Queensbury, New York.
What did FDA cite at Delcath Systems, Inc.?
The regulations cited most in the observations on file for Delcath Systems, Inc. are 21 CFR 820.30 (Design controls), 3 times; 21 CFR 820.50 (Purchasing controls), 2 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time.