Theragen Pharmaceuticals Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Theragen Pharmaceuticals Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Theragen Pharmaceuticals Inc." is on file.

What these totals cover: FDA records filed under the name "Theragen Pharmaceuticals Inc." and its spelling variant "Theragen Pharmaceuticals".

Latest inspection
Nov 4, 2009 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

1 inspection on Nov 4, 2009.

DateSiteProductClassificationFEI
Nov 4, 2009East Windsor, NJFood/CosmeticsNo Action Indicated (NAI)3004205008
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004205008East Windsor, NJ1Nov 4, 2009

Theragen Pharmaceuticals Inc. and the FDA: common questions

Has Theragen Pharmaceuticals Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Theragen Pharmaceuticals 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 Theragen Pharmaceuticals Inc. received an FDA Form 483?

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

When did the FDA last inspect Theragen Pharmaceuticals Inc.?

The most recent FDA inspection on file ended Nov 4, 2009 at East Windsor, NJ and was classified NAI. FDA has 1 inspection of Theragen Pharmaceuticals Inc. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.