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Catalent Belgium SA, Brussels-Capital Region, Belgium – FDA Inspections

Inspection records and compliance data for Catalent Belgium SA in Brussels-Capital Region. 14 FDA inspections on record, 6 Form 483s, last inspected July 12, 2024.

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Company Profile

This profile covers Catalent Belgium SA based in Brussels-Capital Region, Belgium.

FDA Inspection History

FDA inspections
14
OAI
0
VAI
10
NAI
2
Unclassified
2
Form 483s
6
Warning letters
0

First inspected July 20, 2009. Last inspected July 12, 2024.

Most cited issue areas

  • Procedures for sterile drug products2 inspections
  • Cleaning System1 inspection
  • Complete Test Data1 inspection

FDA inspections (14)

DateResultFDA center(s)Insp. #
July 12, 2024Not classifiedHuman Drugs1273463
April 7, 2023VAIHuman Drugs · Drug Quality Assurance1246550
August 19, 2022VAIHuman Drugs · Drug Quality Assurance1177876
January 22, 2020VAIHuman Drugs · Drug Quality Assurance1136201
June 19, 2019VAIBiologics · Vaccines and Allergenic Products1093395
February 15, 2019Not classifiedHuman Drugs1082390
July 31, 2018NAIMedical Devices & Rad Health · Compliance: Devices1061068
July 7, 2017VAIBiologics · Vaccines and Allergenic Products1019956
November 25, 2016NAIAnimal Drugs & Feeds, Human Drugs · Pre-Approval Eval. of Animal Drugs and Food Additives996402
May 28, 2015VAIBiologics · Vaccines and Allergenic Products933183
February 13, 2015VAIHuman Drugs · Drug Quality Assurance915621
January 30, 2013VAIHuman Drugs, Medical Devices & Rad Health · Compliance: Devices818925
June 10, 2011VAIBiologics · Vaccines and Allergenic Products734988
July 20, 2009VAIBiologics · Vaccines and Allergenic Products601425
FDA documents

Form 483s (8)

  • Form 483s · July 12, 2024
  • Form 483s · August 19, 2022
  • Form 483s · October 26, 2021
  • Form 483s · June 19, 2019
  • Form 483s · February 7, 2019
  • Form 483s · July 7, 2017
  • Form 483s · November 25, 2016
  • Form 483s

EIRs (2)

  • EIRs · August 19, 2022
  • EIRs · June 19, 2019
People (4)
Yasamin Ameri
Person
Mihaly S. Ligmond
Person
Jessica Hankins
Person
Viviana Matta
Person
Related Companies (10)

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

Bora Pharmaceuticals Injectables Inc
Jubilant HollisterStier LLC
Patheon Manufacturing Services LLC
CoreRX Inc.
Hospira, Inc., A Pfizer Company
Pfizer Manufacturing Belgium NV
Janssen Pharmaceuticals Inc.
Afton Scientific, LLC
Rovi Pharma Industrial Services S.A.
Steril-Gene Life Sciences Private Ltd
Company Information

Name

Catalent Belgium SA

FEI Number

3007647000

Address

Font Saint-Landry 10 Brussels, Brussels-Capital Region, Belgium

Country

Belgium

ID: f48653bf-84a2-4aeb-bdc3-ca2d0cc4fdf2

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