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•United States

ENDO USA, Inc., Rochester, MI – FDA Inspections

Inspection records and compliance data for ENDO USA, Inc. in Rochester, Michigan. 18 FDA inspections on record (1 OAI), 6 Form 483s, last inspected October 20, 2025.

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Company Profile

This profile covers ENDO USA, Inc. based in Rochester, Michigan, United States.

FDA Inspection History

FDA inspections
18
OAI
1
VAI
15
NAI
1
Unclassified
1
Form 483s
6
Warning letters
0

First inspected July 17, 2009. Last inspected October 20, 2025.

Most cited issue areas

  • Procedures not in writing, fully followed4 inspections
  • Equipment Design, Size and Location3 inspections
  • Procedures for sterile drug products3 inspections

FDA inspections (18)

DateResultFDA center(s)Insp. #
October 20, 2025OAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1287690
June 5, 2025Not classifiedBiologics · Blood and Blood Products1256071
April 14, 2023VAIHuman Drugs · Drug Quality Assurance1202528
October 22, 2021VAIBiologics · Blood and Blood Products1155650
April 15, 2019VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices1086628
August 9, 2018VAIBiologics · Vaccines and Allergenic Products1061939
March 13, 2017VAIHuman Drugs · Drug Quality Assurance1007400
September 28, 2015NAIHuman Drugs · Drug Quality Assurance951005
September 10, 2015VAIHuman Drugs · Drug Quality Assurance947605
February 10, 2014VAIHuman Drugs · Drug Quality Assurance865213
December 28, 2012VAIHuman Drugs · Drug Quality Assurance812198
March 29, 2012VAIHuman Drugs · Drug Quality Assurance774289
August 5, 2011VAIBiologics · Blood and Blood Products739061
June 8, 2011VAIHuman Drugs · Drug Quality Assurance728212
August 31, 2010VAIHuman Drugs · Drug Quality Assurance677583
February 18, 2010VAIHuman Drugs · Drug Quality Assurance646326
September 22, 2009VAIBiologics · Blood and Blood Products615126
July 17, 2009VAIHuman Drugs · Drug Quality Assurance597356
FDA documents

Form 483s (8)

  • Form 483s · October 20, 2025
  • Form 483s · June 5, 2025
  • Form 483s · April 14, 2023
  • Form 483s · October 18, 2021
  • Form 483s · April 15, 2019
  • Form 483s · August 9, 2018
  • Form 483s · August 31, 2010
  • Form 483s
People (6)
Jeffrey D. Meng
Person
Michele L. Forster
Person
Mihaly S. Ligmond
Person
Omotunde Osunsanmi
Person
Amy Graf
Person
Joseph T. Madak
Person
Related Companies (10)

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Fenwal International, Inc.
ROVI Pharma Industrial Services S.A.
B. Braun Medical Inc
Fresenius Medical Care, North America
Amneal Pharmaceuticals Private Limited
Berkshire Sterile Manufacturing, LLC
Company Information

Name

ENDO USA, Inc.

FEI Number

1818977

Address

870 Parkdale Rd, Rochester, Michigan 48307, United States

Country

United States

ID: f2df2e47-8303-4a2c-9881-5e2ecef64f22

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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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