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Patheon Biologics LLC, Saint Louis, MO – FDA Inspections

Inspection records and compliance data for Patheon Biologics LLC in Saint Louis, Missouri. 10 FDA inspections on record, 7 Form 483s, last inspected November 20, 2024.

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Company Profile

This profile covers Patheon Biologics LLC based in Saint Louis, Missouri, United States.

FDA Inspection History

FDA inspections
10
OAI
0
VAI
5
NAI
1
Unclassified
4
Form 483s
7
Warning letters
0

First inspected June 23, 2010. Last inspected November 20, 2024.

FDA inspections (10)

DateResultFDA center(s)Insp. #
November 20, 2024Not classifiedHuman Drugs1251864
December 8, 2023VAIHuman Drugs · Drug Quality Assurance1224734
November 10, 2023Not classifiedHuman Drugs1225829
March 2, 2023VAIHuman Drugs · Drug Quality Assurance1200172
January 24, 2023Not classifiedHuman Drugs1206368
August 2, 2019VAIHuman Drugs · Drug Quality Assurance1099387
October 9, 2018Not classifiedHuman Drugs1072763
February 21, 2014VAIHuman Drugs · Drug Quality Assurance867704
April 3, 2012NAIHuman Drugs · Drug Quality Assurance775547
June 23, 2010VAIHuman Drugs · Drug Quality Assurance669867
FDA documents

Form 483s (8)

  • Form 483s · November 20, 2024
  • Form 483s · December 8, 2023
  • Form 483s · November 10, 2023
  • Form 483s · March 2, 2023
  • Form 483s · January 24, 2023
  • Form 483s · May 2, 2022
  • Form 483s · July 30, 2019
  • Form 483s

EIRs (3)

  • EIRs · November 10, 2023
  • EIRs · March 2, 2023
  • EIRs · August 2, 2019
People (6)
Joseph A. Piechocki
Person
Robert J. Ham
Person
Harnet M. Toure
Person
Li Yongmin
Person
Marie M. Carpunky
Person
Joseph M. Logsdon
Person
Related Companies (10)

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

Evive Biopharmaceutical (Beijing), Ltd.
MacroGenics, Inc
FujiFilm Diosynth Biotechnologies U.S.A., Inc.
Catalent Pharma Solutions, LLC
Apitoria Pharma Private Limited
Shandong Anshun Pharmaceutical Co., Ltd.
Biovectra Inc.
MABXIENCE S.A.U.
Auroactive Pharma Private Limited
Shionogi Pharma Co. Ltd.
Company Information

Name

Patheon Biologics LLC

FEI Number

3003418999

Address

4766 Laguardia Dr, Saint Louis, Missouri 63134, United States

Country

United States

ID: f1012be8-80da-4749-b923-0c97e2b6d47f

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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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