Jubilant Draximage Inc FDA Record
Jubilant Draximage Inc has 4 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jubilant Draximage Inc" is on file.
- Latest recall
- D-0191-2025 · Class II · Nov 22, 2024
- Latest inspection
- Apr 23, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 1 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 1 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0191-2025 | Class II | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction… | Nov 22, 2024 |
| D-1189-2022 | Class II | Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30… | Jun 16, 2022 |
| D-1062-2020 | Class II | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx… | Mar 19, 2020 |
| D-0812-2016 | Class III | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage… | Mar 11, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 23, 2024 | Kirkland, Canada | Drugs | Voluntary Action Indicated (VAI) | 3009003838 |
| Jun 10, 2022 | Kirkland, Canada | Drugs | Voluntary Action Indicated (VAI) | 3009003838 |
| Sep 8, 2017 | Kirkland, Canada | Drugs | No Action Indicated (NAI) | 3009003838 |
| May 19, 2016 | Charleston, SC | Drugs | No Action Indicated (NAI) | 3008230308 |
| Dec 17, 2015 | Kirkland, Canada | Drugs | Voluntary Action Indicated (VAI) | 3009003838 |
| Aug 21, 2014 | Charleston, SC | Drugs | Voluntary Action Indicated (VAI) | 3008230308 |
| Sep 17, 2013 | Kirkland, Canada | Drugs | Voluntary Action Indicated (VAI) | 3009003838 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009003838 | Kirkland, Canada | 5 | Apr 23, 2024 |
| FEI 3008230308 | Charleston, SC | 2 | May 19, 2016 |
Jubilant Draximage Inc and the FDA: common questions
Has Jubilant Draximage Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Jubilant Draximage 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 Jubilant Draximage Inc received an FDA Form 483?
FDA has not published a Form 483 for "Jubilant Draximage Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Jubilant Draximage Inc?
The most recent FDA inspection on file ended Apr 23, 2024 at Kirkland, Canada and was classified VAI. FDA has 7 inspections of Jubilant Draximage Inc on file.
Has Jubilant Draximage Inc had an FDA recall?
Yes. Jubilant Draximage Inc has 4 FDA recalls on record. The most recent started Nov 22, 2024.
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