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Jubilant DraxImage Radiopharmacies FDA Record

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

Jubilant DraxImage Radiopharmacies has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Jubilant DraxImage Radiopharmacies, the most recent on Mar 10, 2016. FDA has published 1 Form 483 for Jubilant DraxImage Radiopharmacies.

What these totals cover: FDA records filed under the name "Jubilant DraxImage Radiopharmacies".

Latest inspection: Mar 23, 2026 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	6	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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.

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Jubilant DraxImage Radiopharmacies FDA Warning Letters

1 warning letter on Mar 10, 2016.

Issued	Subject	Issuing office	Close-out letter
Mar 10, 2016 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Jubilant DraxImage Radiopharmacies Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Mar 13, 2024 · Document on fda.gov	483	3009339218

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

6 inspections from Apr 12, 2013 to Mar 23, 2026.

Date	Site	Product	Classification	FEI
Mar 23, 2026	Mobile, AL	Drugs	Voluntary Action Indicated (VAI)	3006563584
Mar 13, 2024	Orlando, FL	Drugs	Voluntary Action Indicated (VAI)	3009339218
Jul 3, 2017	Kansas City, MO	Drugs	Voluntary Action Indicated (VAI)	3008364285
Sep 13, 2016	Mobile, AL	Drugs	No Action Indicated (NAI)	3006563584
Jan 9, 2015	Kansas City, MO	Drugs	Official Action Indicated (OAI)	3008364285
Apr 12, 2013	Mobile, AL	Drugs	Voluntary Action Indicated (VAI)	3006563584

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Jubilant DraxImage Radiopharmacies: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 10, 2016.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006563584	Mobile, AL	3	Mar 23, 2026
FEI 3009339218	Orlando, FL	1	Mar 13, 2024
FEI 3008364285	Kansas City, MO	2	Jul 3, 2017

Jubilant DraxImage Radiopharmacies and the FDA: common questions

Has Jubilant DraxImage Radiopharmacies received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Jubilant DraxImage Radiopharmacies. The most recent is dated Mar 10, 2016.

Has Jubilant DraxImage Radiopharmacies received an FDA Form 483?

FDA has published 1 Form 483 for Jubilant DraxImage Radiopharmacies in its reading room, the most recent dated Mar 13, 2024. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Jubilant DraxImage Radiopharmacies?

The most recent FDA inspection on file ended Mar 23, 2026 at Mobile, AL and was classified VAI. FDA has 6 inspections of Jubilant DraxImage Radiopharmacies on file, 1 of them classified OAI (official action indicated).

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