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Details of Fresenius Se & Co. Kgaa's U.S. FDA Inspections. Original Data: FDA Inspection Database

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Fenwal Inc

Fresenius Kabi

Fresenius Kabi AB

Fresenius Kabi Austria GmbH

Fresenius Kabi Austria Gmbh

Fresenius Kabi Deutschland GmbH

Fresenius Kabi Norge As

Fresenius Kabi Oncology Ltd

Fresenius Kabi USA, LLC

Fresenius Medical Care North America

Societa Chimica Mugello S.r.l.

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No Action Indicated

Official Action Indicated

Voluntary Action Indicated

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2017-08-18

2017-08-07

2017-06-30

2017-06-28

2017-05-26

2017-04-14

2017-03-30

2017-03-17

2017-02-07

2017-02-01

2015-05-05

2015-04-14

2014-11-07

2014-10-24

2014-10-06

2014-09-26

2013-12-20

2013-12-17

2013-07-16

2013-01-18

2012-12-27

2012-12-20

2012-11-20

2012-08-23

2012-05-04

2012-03-22

2011-12-20

2011-08-29

2011-07-29

2011-07-08

2011-05-27

2011-03-25

2010-06-15

2010-01-29

2010-01-21

2010-01-13

2009-12-03

2009-11-17

2009-11-06

2009-09-25

2009-09-17

2009-07-03

2009-03-20

2009-03-05

2009-03-03

2008-10-31

2008-10-22

2008-10-07

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Birmingham

Friedberg

Grand Island

Graz

Halden

Lake Zurich

Linz

Melrose Park

Nadia

Oregon

Uppsala

Vicchio

Warrendale

Wilson

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AT

DE

IN

IT

NO

SE

US

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-03-22
Vicchio
IT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-03-03
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-09-25
Lake Zurich
IL
US
60047-8930
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-01-21
Lake Zurich
IL
US
60047-8930
CHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-01-21
Lake Zurich
IL
US
60047-8930
CHI
CDRH
Postmarket Assurance: Dev...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-01-29
Melrose Park
IL
US
60160-1002
CHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-01-29
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-01-29
Melrose Park
IL
US
60160-1002
CHI
CVM
Monitoring of Marketed An...

INSPECTIONS & REGISTRATIONS

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No Action Indicated
2011-12-20
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-05-04
Lake Zurich
IL
US
60047-8930
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-05-04
Lake Zurich
IL
US
60047-8930
CHI
CDER
Postmarket Surv. and Epid...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-11-20
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-11-20
Melrose Park
IL
US
60160-1002
CHI
CVM
Monitoring of Marketed An...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2013-12-17
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-10-06
Lake Zurich
IL
US
60047-8930
CHI
CDER
Postmarket Surv. and Epid...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2015-04-14
Melrose Park
IL
US
60160-1002
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-06-15
Oregon
OH
US
43616-1337
CIN
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-12-27
Oregon
OH
US
43616-1337
CIN
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-12-27
Oregon
OH
US
43616-1337
CIN
CDRH
Postmarket Assurance: Dev...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2008-10-22
Birmingham
AL
US
35211-6942
NOL
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2008-10-31
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-03-05
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-09-17
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2010-01-13
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Official Action Indicated
2011-07-08
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2011-08-29
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-10-24
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-10-24
Grand Island
NY
US
14072-2028
NYK
CFSAN
Foodborne Biological Haza...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-07-03
Graz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-11-06
Nadia
IN
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-11-17
Halden
NO
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-12-03
Graz
AT
ORA
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-03-25
Graz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2011-07-29
Linz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-08-23
Halden
NO
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Official Action Indicated
2013-01-18
Nadia
IN
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2013-07-16
Graz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-12-20
Halden
NO
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-11-07
Linz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2008-10-07
Warrendale
PA
US
15086-7521
PHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-05-27
Warrendale
PA
US
15086-7521
PHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-05-27
Warrendale
PA
US
15086-7521
PHI
CDRH
Postmarket Assurance: Dev...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-12-20
Warrendale
PA
US
15086-7521
PHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-12-20
Warrendale
PA
US
15086-7521
PHI
CDRH
Postmarket Assurance: Dev...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2015-05-05
Warrendale
PA
US
15086-7521
PHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-06-30
Oregon
OH
US
43616-1337
CIN
CDRH
Postmarket Assurance: Dev...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-04-14
Lake Zurich
IL
US
60047-8930
CHI
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-06-28
Oregon
OH
US
43616-1849
CIN
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-03-30
Grand Island
NY
US
14072-2028
NYK
CDER
Postmarket Surv. and Epid...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-03-30
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-03-17
Graz
AT
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-05-26
Halden
NO
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-02-01
Grand Island
NY
US
14072-2028
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-06-30
Oregon
OH
US
43616-1337
CIN
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-08-18
Wilson
NC
US
27893-9412
ATL
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-02-07
Uppsala
SE
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-09-26
Friedberg
DE
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-03-20
Lake Zurich
IL
US
60047-8930
CHI
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-08-07
Lake Zurich
IL
US
60047-8930
CHI
CDRH
Compliance: Devices

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