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Jubilant DraxImage Inc., Dba Jubilant Radiopharma FDA Inspection Record

FEI 3009003838 · Inspections, Form 483s, warning letters and import refusals

Jubilant DraxImage Inc., Dba Jubilant Radiopharma is an FDA-registered facility (FEI 3009003838) located in Kirkland, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2024: Voluntary Action Indicated (VAI)
Inspections on record
5 (4 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Nov 22, 2024
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 23, 2024Voluntary Action Indicated (VAI)No citations listed
Jun 10, 2022Voluntary Action Indicated (VAI)Equipment for Environmental Control (21 CFR 211.46(b))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written record of investigation incomplete (21 CFR 211.192)
Sep 8, 2017No Action Indicated (NAI)No citations listed
Dec 17, 2015Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
No written record of investigation (21 CFR 211.192)
Sep 17, 2013Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Nov 22, 2024Class IID-0191-2025Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose…
Failed Stability Specifications
Jun 16, 2022Class IID-1189-2022Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per…
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Mar 19, 2020Class IID-1062-2020DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg…
Failed Stability Specifications
Mar 11, 2016Class IIID-0812-2016SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant…
Labeling: Label Error on Declared Strength

FDA record score

15 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

7 records behind this number
RecordDatePoints x age weightAdds
Class II recall D-0191-2025, this FEI as the recalling firmNov 22, 20244 x 14
Inspection classified VAIApr 23, 20246 x 0.63.6
Inspection classified VAIJun 10, 20226 x 0.63.6
Class II recall D-1189-2022, this FEI as the recalling firmJun 16, 20224 x 0.62.4
Class II recall D-1062-2020, this FEI as the recalling firmMar 19, 20204 x 0.251
Inspection classified VAIDec 17, 201510 years or older, so it adds no points0
Inspection classified VAISep 17, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Jubilant Draximage Inc.
Location
Kirkland (CA)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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