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•United States

Strides Pharma, Inc., Chestnut Ridge, NY – FDA Inspections

Inspection records and compliance data for Strides Pharma, Inc. in Chestnut Ridge, New York. 10 FDA inspections on record, 3 Form 483s, last inspected December 23, 2025.

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Company Profile

This profile covers Strides Pharma, Inc. based in Chestnut Ridge, New York, United States.

FDA Inspection History

FDA inspections
10
OAI
0
VAI
6
NAI
3
Unclassified
1
Form 483s
3
Warning letters
0

First inspected August 7, 2009. Last inspected December 23, 2025.

Most cited issue areas

  • Written procedures not established/followed2 inspections
  • Control procedures to monitor and validate performance1 inspection
  • In-process materials characteristics testing1 inspection

FDA inspections (10)

DateResultFDA center(s)Insp. #
December 23, 2025Not classifiedHuman Drugs, Medical Devices & Rad Health1292202
February 8, 2022VAIHuman Drugs · Drug Quality Assurance1162483
August 23, 2019NAIHuman Drugs · Bioresearch Monitoring1103039
June 5, 2019VAIHuman Drugs · Generic Drug Evaluation1092153
March 16, 2017VAIHuman Drugs · Drug Quality Assurance1009619
June 4, 2015VAIHuman Drugs · Drug Quality Assurance932525
February 19, 2013VAIHuman Drugs · Drug Quality Assurance817330
April 4, 2012NAIHuman Drugs · Bioresearch Monitoring775741
May 4, 2011NAIHuman Drugs · Drug Quality Assurance723405
August 7, 2009VAIHuman Drugs · Drug Quality Assurance603167
FDA documents

Form 483s (4)

  • Form 483s · December 23, 2025
  • Form 483s · February 20, 2022
  • Form 483s · June 5, 2019
  • Form 483s · June 4, 2015

EIRs (1)

  • EIRs · February 8, 2022
People (4)
Mindy M. Chou
Person
Sony Mathews
Person
Janet A. Rajan
Person
Guerlain Ulysse
Person
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Otsuka Pharmaceutical Co., Ltd.
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Company Information

Name

Strides Pharma, Inc.

FEI Number

2434223

Address

1 Ram Ridge Rd, Chestnut Ridge, New York 10977, United States

Country

United States

ID: e9e4da51-c260-486c-8969-86d64b9b36af

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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