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Acorda Therapeutics, Inc. FDA Record

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

Latest inspection NAI · Aug 18, 2020
Last warning letter 2013

Inspections 11

1 OAI

Recalls 0 0 Class I

Warning letters 2 Latest Jul 25, 2013

510(k) clearances 0 None on file

Acorda Therapeutics, Inc. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Acorda Therapeutics, Inc., the most recent on Jul 25, 2013.

What these totals cover: FDA records filed under the name "Acorda Therapeutics, Inc." and its spelling variant "Acorda Therapeutics".

Latest inspection: Aug 18, 2020 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	11	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Acorda Therapeutics, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Acorda Therapeutics, Inc.: 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	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	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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Acorda Therapeutics, Inc. FDA Warning Letters

2 warning letters from May 10, 2012 to Jul 25, 2013.

Issued	Subject	Issuing office	Close-out letter
Jul 25, 2013 · Record page
May 10, 2012 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

11 inspections from Feb 26, 2009 to Aug 18, 2020.

Date	Site	Product	Classification	FEI
Aug 18, 2020	Pearl River, NY	Drugs	No Action Indicated (NAI)	3002457563
Jul 19, 2019	Pearl River, NY	Drugs	No Action Indicated (NAI)	3002457563
Jan 18, 2019	Pearl River, NY	Drugs	No Action Indicated (NAI)	3002457563
Feb 29, 2016	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563
Aug 25, 2014	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563
Dec 19, 2013	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563
Jan 16, 2013	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563
Dec 7, 2012	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563
Sep 9, 2011	Pearl River, NY	Drugs	Official Action Indicated (OAI)	3002457563
Aug 11, 2011	Pearl River, NY	Drugs	No Action Indicated (NAI)	3002457563
Feb 26, 2009	Pearl River, NY	Drugs	Voluntary Action Indicated (VAI)	3002457563

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 2 compliance actions under Acorda Therapeutics, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 25, 2013.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other 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 3002457563	Pearl River, NY	11	Aug 18, 2020

Acorda Therapeutics, Inc. and the FDA: common questions

Has Acorda Therapeutics, Inc. received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Acorda Therapeutics, Inc.. The most recent is dated Jul 25, 2013.

Has Acorda Therapeutics, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Acorda Therapeutics, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Acorda Therapeutics, Inc.?

The most recent FDA inspection on file ended Aug 18, 2020 at Pearl River, NY and was classified NAI. FDA has 11 inspections of Acorda Therapeutics, Inc. on file, 1 of them classified OAI (official action indicated).

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