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NorthStar Medical Radioisotopes, LLC FDA Record

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

Latest inspection NAI · Sep 8, 2023
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

NorthStar Medical Radioisotopes, LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "NorthStar Medical Radioisotopes, LLC" is on file.

What these totals cover: FDA records filed under the name "NorthStar Medical Radioisotopes, LLC" and its spelling variant "Northstar Medical Radioisotopes".

Latest inspection: Sep 8, 2023 · NAI

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	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

NorthStar Medical Radioisotopes, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

NorthStar Medical Radioisotopes, LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	2	0	0	0	0
2018	0	0	0	0	0
2017	0	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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Recent FDA inspections

3 inspections from May 31, 2019 to Sep 8, 2023.

Date	Site	Product	Classification	FEI
Sep 8, 2023	Madison, WI	Drugs	No Action Indicated (NAI)	3010883189
Aug 14, 2019	Columbia, MO	Drugs	Voluntary Action Indicated (VAI)	3012789825
May 31, 2019	Beloit, WI	Drugs	Voluntary Action Indicated (VAI)	3012785838

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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010883189	Madison, WI	1	Sep 8, 2023
FEI 3012789825	Columbia, MO	1	Aug 14, 2019
FEI 3012785838	Beloit, WI	1	May 31, 2019

NorthStar Medical Radioisotopes, LLC and the FDA: common questions

Has NorthStar Medical Radioisotopes, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "NorthStar Medical Radioisotopes, LLC" 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 NorthStar Medical Radioisotopes, LLC received an FDA Form 483?

FDA has not published a Form 483 for "NorthStar Medical Radioisotopes, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect NorthStar Medical Radioisotopes, LLC?

The most recent FDA inspection on file ended Sep 8, 2023 at Madison, WI and was classified NAI. FDA has 3 inspections of NorthStar Medical Radioisotopes, LLC on file.

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