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Ionetix Corporation

FDA Regulatory Profile

Ionetix Corporation has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Ionetix Corporation" and its spelling variant "Ionetix".

Latest inspection: Jul 23, 2026 · VAI

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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	10	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Ionetix Corporation'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	2	0	0	0	0
2025	3	0	0	0	0
2024	1	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	2	0	0	0	0
2020	0	0	0	0	0
2019	1	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.

Recent FDA inspections

10 inspections from Oct 25, 2019 to Jul 23, 2026.

Date	Site	Product	Classification	FEI
Jul 23, 2026	Jenkintown, PA	Drugs	Voluntary Action Indicated (VAI)	3015287791
Apr 2, 2026	Sarasota, FL	Drugs	Voluntary Action Indicated (VAI)	3013422537
Oct 31, 2025	Kansas City, KS	Drugs	Voluntary Action Indicated (VAI)	3015265824
Sep 26, 2025	Miami Beach, FL	Drugs	Voluntary Action Indicated (VAI)	3022114900
May 1, 2025	Miami, FL	Drugs	Voluntary Action Indicated (VAI)	3017953815
Jan 19, 2024	Pittsburgh, PA	Drugs	Voluntary Action Indicated (VAI)	3016460801
Sep 14, 2023	El Paso, TX	Drugs	Voluntary Action Indicated (VAI)	3016458643
Jun 30, 2021	Jenkintown, PA	Drugs	No Action Indicated (NAI)	3015287791
Feb 25, 2021	Kansas City, KS	Drugs	No Action Indicated (NAI)	3015265824
Oct 25, 2019	Sarasota, FL	Drugs	Voluntary Action Indicated (VAI)	3013422537

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

7 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3015287791	Jenkintown, PA	2	Jul 23, 2026
FEI 3013422537	Sarasota, FL	2	Apr 2, 2026
FEI 3015265824	Kansas City, KS	2	Oct 31, 2025
FEI 3022114900	Miami Beach, FL	1	Sep 26, 2025
FEI 3017953815	Miami, FL	1	May 1, 2025
FEI 3016460801	Pittsburgh, PA	1	Jan 19, 2024
FEI 3016458643	El Paso, TX	1	Sep 14, 2023

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