Delcath Systems Inc. FDA Record

Summary

FDA record by year

Delcath Systems Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

7 inspections from Nov 29, 2012 to Sep 11, 2026.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Delcath Systems Inc. and the FDA: common questions

Has Delcath Systems Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Delcath Systems Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Delcath Systems Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Delcath Systems Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Delcath Systems Inc.?

The most recent FDA inspection on file ended Sep 11, 2026 at Queensbury, NY and was classified NAI. FDA has 7 inspections of Delcath Systems Inc. on file, 1 of them classified OAI (official action indicated).