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Atlas Pharmaceuticals, LLC

FDA Regulatory Profile

Atlas Pharmaceuticals, LLC has 1 FDA recall, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Atlas Pharmaceuticals, LLC" and its spelling variant "Atlas Pharmaceuticals".

Latest recall: D-0144-2020 · Class II · Aug 28, 2019
Latest inspection: May 21, 2021 · 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	1	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	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

Atlas Pharmaceuticals, 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	Recall records
2026	0	0	0	0
2025	0	0	0	0
2024	0	0	0	0
2023	0	0	0	0
2022	0	0	0	0
2021	1	0	0	0
2020	0	0	0	0
2019	0	0	0	1
2018	0	0	1	0
2017	1	1	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 recalls

1 recall record on Aug 28, 2019.

Number	Class	Product	Date
D-0144-2020	Class II	Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas…	Aug 28, 2019

Recent FDA inspections

4 inspections from Dec 21, 2011 to May 21, 2021.

Date	Site	Product	Classification	FEI
May 21, 2021	Phoenix, AZ	Drugs	Voluntary Action Indicated (VAI)	3013030904
Sep 26, 2017	Phoenix, AZ	Drugs	Official Action Indicated (OAI)	3013030904
May 30, 2014	Phoenix, AZ	Veterinary	Voluntary Action Indicated (VAI)	3013030904
Dec 21, 2011	Phoenix, AZ	Veterinary	No Action Indicated (NAI)	3013030904

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Atlas Pharmaceuticals, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 11, 2018.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013030904	Phoenix, AZ	4	May 21, 2021

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