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•Netherlands

Janssen Biologics B.V., Leiden, Netherlands – FDA Inspections

Inspection records and compliance data for Janssen Biologics B.V. in Leiden. 7 FDA inspections on record, last inspected June 01, 2023.

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Company Profile

This profile covers Janssen Biologics B.V. based in Leiden, Netherlands.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
4
NAI
3
Form 483s
0
Warning letters
0

First inspected July 6, 2010. Last inspected June 1, 2023.

FDA inspections (7)

DateResultFDA center(s)Insp. #
June 1, 2023VAIHuman Drugs · Drug Quality Assurance1272273
October 11, 2018VAIHuman Drugs · Drug Quality Assurance1126291
June 15, 2018NAIHuman Drugs · Drug Quality Assurance1076442
May 27, 2016NAIHuman Drugs · Drug Quality Assurance975458
July 11, 2014VAIHuman Drugs · Drug Quality Assurance891657
September 28, 2012VAIHuman Drugs · Drug Quality Assurance813923
July 6, 2010NAIHuman Drugs · Drug Quality Assurance679919
FDA documents

Form 483s (2)

  • Form 483s · September 21, 2012
  • Form 483s
People (2)
Rebeca Rodriguez
Person
Patric C. Klotzbuecher
Person
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FUJIFILM Diosynth Biotechnologies UK Limited
Otsuka Pharmaceutical Co., Ltd.
Reliable Biopharmaceutical LLC
Biocon Limited
Apitoria Pharma Private Limited
MRIGlobal
Bachem AG
Company Information

Name

Janssen Biologics B.V.

FEI Number

3002806632

Address

Einsteinweg 101, Leiden, Netherlands

Country

Netherlands

ID: 2e04e15b-1d3c-493d-b2d0-dcbc2108639b

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