Helsinn Birex Pharmaceuticals Ltd., Mulhuddart, Ireland – FDA Inspections

Inspection records and compliance data for Helsinn Birex Pharmaceuticals Ltd. in Mulhuddart. 7 FDA inspections on record, last inspected September 08, 2023.

Company Profile

This profile covers Helsinn Birex Pharmaceuticals Ltd. based in Mulhuddart, Ireland.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 3
NAI: 2
Unclassified: 2
Form 483s: 0
Warning letters: 0

First inspected May 27, 2010. Last inspected September 8, 2023.

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
September 8, 2023	Not classified	Human Drugs	1219438
July 15, 2022	VAI	Human Drugs · Drug Quality Assurance	1272910
October 25, 2019	VAI	Human Drugs · Drug Quality Assurance	1123956
September 22, 2017	Not classified	Human Drugs	1035450
June 3, 2016	NAI	Human Drugs · Drug Quality Assurance	973919
February 21, 2014	NAI	Human Drugs · Drug Quality Assurance	887344
May 27, 2010	VAI	Human Drugs · Drug Quality Assurance	710425

FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

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

Gilead Sciences Ireland UC

Takeda Ireland Ltd

NORTON (WATERFORD) LIMITED

Mylan Teoranta

Amneal Ireland Limited

FDC Limited

Balkanpharma Dupnitsa AD

INDELPA, S.A DE C.V

STA Pharmaceutical Switzerland SA

AstraZeneca UK Ltd.