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Custom RX LLC

FDA Regulatory Profile

Custom RX LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Custom RX LLC" and its spelling variant "Custom Rx".

Latest inspection: Jul 22, 2021 · NAI

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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	3	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA Record by Year

Custom RX LLC'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
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	1	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	1
2017	1	1	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

3 inspections from Aug 28, 2014 to Jul 22, 2021.

Date	Site	Product	Classification	FEI
Jul 22, 2021	Wichita, KS	Drugs	No Action Indicated (NAI)	3013444075
Aug 15, 2017	Wichita, KS	Drugs	Official Action Indicated (OAI)	3013444075
Aug 28, 2014	Minneapolis, MN	Drugs	Voluntary Action Indicated (VAI)	3003316042

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013444075	Wichita, KS	2	Jul 22, 2021
FEI 3003316042	Minneapolis, MN	1	Aug 28, 2014

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