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Details of Amri's U.S. FDA Inspections. Original Data: FDA Inspection Database

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AMRI

AMRI Rensselaer, Inc.

Albany Molecular Research Inc

Albany Molecular Research Inc.

Cedarburg Hauser Pharmaceuticals, Inc.

Cedarburg Pharmaceuticals Inc

Crystal Pharma, S.A.U.

Euticals Group SpA

Euticals Inc

Euticals SAS

OSO Bio Pharmaceuticals Manufacturing, LLC

OSO BioPharmaceuticals Manufacturing, LLC

Prime European Therapeuticals S.p.A., abbr Euticals S.p.A.

Prime European Therapeuticals SPA

Prime European Therapeuticals SpA dba Euticals SpA

SSCI

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No Action Indicated

No Action Indicated

Official Action Indicated

Voluntary Action Indicated

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2017-11-09

2017-05-24

2017-04-28

2017-03-31

2017-02-09

2016-07-15

2016-07-13

2016-07-05

2015-07-17

2015-06-25

2015-06-05

2015-05-22

2015-02-05

2014-11-18

2014-11-14

2014-11-13

2014-09-25

2014-08-08

2014-07-17

2014-05-02

2014-03-28

2014-03-21

2014-01-15

2013-12-12

2013-08-23

2013-07-18

2013-04-04

2013-01-30

2012-11-23

2012-09-21

2012-04-19

2012-03-29

2012-01-06

2011-12-22

2011-09-15

2011-09-08

2011-07-22

2011-06-28

2011-06-23

2011-06-13

2011-06-10

2010-12-01

2010-09-20

2010-08-18

2010-05-13

2010-04-22

2010-04-07

2010-04-01

2010-03-12

2009-12-14

2009-10-22

2009-07-22

2009-06-12

2009-05-27

2008-11-07

2008-10-27

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Albany

Albuquerque

Boecillo

Bon Encontre

Burlington

Denver

Flintshire, Wales

Grafton

Lodi

Origgio

Rensselaer

Rozzano

Rozzano (Mi)

Springfield

Tonneins

Varese

West Lafayette

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ES

FR

IT

UK

US

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-04-22
Springfield
MO
US
65807-1229
KAN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-04-22
Springfield
MO
US
65807-1229
KAN
CVM
Monitoring of Marketed An...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-12-14
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-09-20
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2011-06-10
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-04-04
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2010-04-07
Rensselaer
NY
US
12144-2900
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-03-29
Rensselaer
NY
US
12144-2900
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-01-30
Rensselaer
NY
US
12144-2900
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-01-15
Rensselaer
NY
US
12144-2900
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2015-05-22
Rensselaer
NY
US
12144-2900
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-06-28
Burlington
MA
US
01803-6809
NWE
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Official Action Indicated
2010-04-01
Burlington
MA
US
01803-6809
NWE
CDRH
Compliance: Devices

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-11-14
Flintshire, Wales
UK
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-07-22
Flintshire, Wales
UK
ORA
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-12-12
Albany
NY
US
12203-5154
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-06-13
Albany
NY
US
12203-5154
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-08-18
Albany
NY
US
12203-5154
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2008-11-07
Albuquerque
NM
US
87110
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2010-03-12
Albuquerque
NM
US
87110
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-04-19
Albuquerque
NM
US
87110
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-05-27
Denver
CO
US
80221
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2009-05-27
Denver
CO
US
80221
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-05-02
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-07-18
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2011-06-28
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Official Action Indicated
2010-04-01
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-06-12
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-08-23
Albuquerque
NM
US
87110-6342
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-07-17
Albuquerque
NM
US
87110-6342
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2015-06-05
Albuquerque
NM
US
87110-6342
DEN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-05-24
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-11-09
Rensselaer
NY
US
12144-2951
NYK
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2016-07-13
Burlington
MA
US
01803-6809
NWE
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2016-07-05
Albany
NY
US
12203-5154
NYK
CVM
Pre-Approval Eval. of Ani...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2013-04-04
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2016-07-15
Grafton
WI
US
53024-9436
MIN
CVM
Monitoring of Marketed An...

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2016-07-15
Grafton
WI
US
53024-9436
MIN
CDER
Drug Quality Assurance

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2008-10-27
Boecillo
ES
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-06-23
Boecillo
ES
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-03-21
Boecillo
ES
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-01-06
Springfield
MO
US
65807-1229
KAN
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-01-06
Springfield
MO
US
65807-1229
KAN
CVM
Monitoring of Marketed An...
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-08-08
Springfield
MO
US
65807-1229
KAN
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-08-08
Springfield
MO
US
65807-1229
KAN
CVM
Monitoring of Marketed An...
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-07-22
Rozzano
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-05-13
Origgio
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-09-08
Lodi
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-09-15
Rozzano (Mi)
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2012-09-21
Varese
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2012-11-23
Rozzano
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2014-03-28
Origgio
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-09-25
Lodi
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-11-13
Tonneins
FR
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2014-11-18
Bon Encontre
FR
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2015-02-05
Rozzano (Mi)
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2015-07-17
Varese
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-04-28
Lodi
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
Voluntary Action Indicated
2017-03-31
Rozzano
IT
ORA
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-02-09
Springfield
MO
US
65807-1229
KAN
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-02-09
Springfield
MO
US
65807-1229
KAN
CVM
Monitoring of Marketed An...
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-02-09
Springfield
MO
US
65807-1229
KAN
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2017-02-09
Springfield
MO
US
65807-1229
KAN
CVM
Monitoring of Marketed An...
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2015-06-25
West Lafayette
IN
US
47906-1076
DET
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2011-12-22
West Lafayette
IN
US
47906-1076
DET
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2010-12-01
West Lafayette
IN
US
47906-1076
DET
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

INSPECTIONS & REGISTRATIONS

Contact the Supplier
No Action Indicated
2009-10-22
West Lafayette
IN
US
47906-1076
DET
CDER
Drug Quality Assurance
Amri-Company-Banner
MEET WITH US AT OUR NEXT EVENT

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