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•United States

Patheon Manufacturing Services LLC, Ridgefield, NJ – FDA Inspections

Inspection records and compliance data for Patheon Manufacturing Services LLC in Ridgefield, New Jersey. 13 FDA inspections on record, 3 Form 483s, last inspected May 19, 2026.

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Company Profile

This profile covers Patheon Manufacturing Services LLC based in Ridgefield, New Jersey, United States.

FDA Inspection History

FDA inspections
13
OAI
0
VAI
8
NAI
3
Unclassified
2
Form 483s
3
Warning letters
0

First inspected March 19, 2009. Last inspected May 19, 2026.

Most cited issue areas

  • Procedures for sterile drug products4 inspections
  • Investigations of discrepancies, failures2 inspections
  • Actual vs. theoretical yields not determined1 inspection

FDA inspections (13)

DateResultFDA center(s)Insp. #
May 19, 2026Not classifiedBiologics · Vaccines and Allergenic Products1317726
August 30, 2024Not classifiedHuman Drugs1271322
June 13, 2024VAIBiologics · Vaccines and Allergenic Products1230469
March 18, 2024VAIHuman Drugs · Drug Quality Assurance1230688
December 17, 2018VAIMedical Devices & Rad Health · Compliance: Devices1076243
December 7, 2017VAIHuman Drugs · Drug Quality Assurance1039401
August 26, 2015NAIHuman Drugs · Drug Quality Assurance938525
January 21, 2014VAIHuman Drugs · Drug Quality Assurance861702
September 12, 2012NAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance795428
June 21, 2011VAIHuman Drugs · Drug Quality Assurance731289
December 21, 2010VAIHuman Drugs · Drug Quality Assurance697759
September 2, 2010VAIHuman Drugs · Drug Quality Assurance682898
March 19, 2009NAIMedical Devices & Rad Health · Bioresearch Monitoring571628
FDA documents

Form 483s (3)

  • Form 483s · May 19, 2026
  • Form 483s · August 30, 2024
  • Form 483s · March 18, 2024
People (6)
Stephenie M. Ortiz
Person
Paige R Moore
Person
Zhong Li
Person
Ekaterina Allen
Person
Shafiq S. Ahadi
Person
Laurel A. Beer
Person
Related Companies (10)

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Alliance Medical Products, Inc. DBA Siegfried Company
Holopack Verpackungstechnik GmbH
Summit Biosciences Inc.
Colgate-Palmolive Company
Liebel-Flarsheim Company LLC
Cetylite Industries, Inc.
Company Information

Name

Patheon Manufacturing Services LLC

FEI Number

2246315

Address

1125 Pleasantview Ter, Ridgefield, New Jersey 07657, United States

Country

United States

ID: a58b7a37-69a3-45d1-a590-72294e5e7a17

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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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