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•United States

Acorda Therapeutics, Inc., Pearl River, NY – FDA Inspections

Inspection records and compliance data for Acorda Therapeutics, Inc. in Pearl River, New York. 11 FDA inspections on record (1 OAI), last inspected August 18, 2020.

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Company Profile

This profile covers Acorda Therapeutics, Inc. based in Pearl River, New York, United States.

FDA Inspection History

FDA inspections
11
OAI
1
VAI
6
NAI
4
Form 483s
0
Warning letters
0

First inspected February 26, 2009. Last inspected August 18, 2020.

Most cited issue areas

  • Failure to review ADE information3 inspections
  • Failure by applicant to report ADE2 inspections
  • Failure to develop written procedures2 inspections

FDA inspections (11)

DateResultFDA center(s)Insp. #
August 18, 2020NAIHuman Drugs · Drug Quality Assurance1130049
July 19, 2019NAIHuman Drugs · Bioresearch Monitoring1100682
January 18, 2019NAIHuman Drugs · Bioresearch Monitoring1079179
February 29, 2016VAIHuman Drugs · Bioresearch Monitoring975465
August 25, 2014VAIHuman Drugs · Bioresearch Monitoring892026
December 19, 2013VAIHuman Drugs · Bioresearch Monitoring860326
January 16, 2013VAIHuman Drugs · Postmarket Surv. and Epidemiology812545
December 7, 2012VAIHuman Drugs · Bioresearch Monitoring812547
September 9, 2011OAIHuman Drugs · Bioresearch Monitoring739375
August 11, 2011NAIHuman Drugs · Bioresearch Monitoring739376
February 26, 2009VAIHuman Drugs · Bioresearch Monitoring564405
FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Naveed Iqbal, M.D.
Marksans Pharmaceuticals Ltd
Jared C. Barlow, M.D.
Miguel-Angel Perales, MD
Ellen Ritchie, MD
Albany College Pharmacy IRB
William M. Kufs, MD
Charles Marmar, M.D.
Paula J. Busse, M.D.
Scott T. Tagawa, M.D.
Company Information

Name

Acorda Therapeutics, Inc.

FEI Number

3002457563

Address

2 Blue Hill Plz Fl 3, Pearl River, New York 10965, United States

Country

United States

ID: 7c9c61c1-bfd5-4162-98ba-53f58085d345

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