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Company
•United States

Patheon Pharmaceuticals Inc., Cincinnati, OH – FDA Inspections

Inspection records and compliance data for Patheon Pharmaceuticals Inc. in Cincinnati, Ohio. 17 FDA inspections on record (1 OAI), 4 Form 483s, last inspected September 26, 2025.

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Company Profile

This profile covers Patheon Pharmaceuticals Inc. based in Cincinnati, Ohio, United States.

FDA Inspection History

FDA inspections
17
OAI
1
VAI
10
NAI
5
Unclassified
1
Form 483s
4
Warning letters
0

First inspected March 24, 2010. Last inspected September 26, 2025.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance2 inspections
  • Procedures not in writing, fully followed2 inspections
  • SOPs not followed / documented2 inspections

FDA inspections (17)

DateResultFDA center(s)Insp. #
September 26, 2025VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1281564
July 24, 2023Not classifiedHuman Drugs1211249
April 21, 2023NAIHuman Drugs · Drug Quality Assurance1204466
January 14, 2020NAIHuman Drugs · Drug Quality Assurance1117783
February 15, 2019OAIHuman Drugs · Generic Drug Evaluation1079809
February 14, 2018VAIHuman Drugs · Drug Quality Assurance1040994
March 2, 2017VAIHuman Drugs · Drug Quality Assurance1003802
March 11, 2016VAIHuman Drugs · Drug Quality Assurance966241
October 30, 2014VAIHuman Drugs · Drug Quality Assurance908474
June 18, 2014NAIHuman Drugs · Drug Quality Assurance884564
August 26, 2013VAIHuman Drugs · Drug Quality Assurance847969
May 13, 2013VAIHuman Drugs · Drug Quality Assurance832290
August 16, 2012VAIHuman Drugs · Drug Quality Assurance793752
January 12, 2012VAIHuman Drugs · Drug Quality Assurance769732
March 24, 2011VAIHuman Drugs · Drug Quality Assurance722010
January 31, 2011NAIHuman Drugs · Drug Quality Assurance707714
March 24, 2010NAIHuman Drugs · Drug Quality Assurance653143
FDA documents

Form 483s (3)

  • Form 483s · September 26, 2025
  • Form 483s · February 14, 2018
  • Form 483s · August 21, 2015

EIRs (4)

  • EIRs · January 14, 2020
  • EIRs · December 13, 2019
  • EIRs · February 14, 2018
  • EIRs · March 1, 2017

Other FDA documents (1)

  • Other FDA documents
Other regulators (1)
  • UK MHRA · 1 inspection · last January 17, 2017
People (5)
Tarun D. Mehta
Person
Lindsey Schwierjohann
Person
Nicholas M. Buscher
Person
Andrea LC Waymire
Person
Garry L. Hedgepeth
Person
Related Companies (10)

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

Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany
Sumitomo Dainippon Pharma Co., Ltd.
Latina Pharma S.p.A.
BioMarin International Limited
Pharmaron (Ningbo) Technology Development Co., Ltd.
Cipla, Ltd.
Amgen Manufacturing Ltd
Gland Pharma Limited
Biological E. Limited
Sinopep-Allsino Biopharmaceutical Co., Ltd.
Company Information

Name

Patheon Pharmaceuticals Inc.

FEI Number

1510437

Address

2110 E Galbraith Rd, Cincinnati, Ohio 45237, United States

Country

United States

ID: f1ef6b53-3c20-4c22-9ef3-fd05fdb9f35b

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