01 17Roche Diagnostics GmbH
01 12No Action Indicated
02 5Voluntary Action Indicated
01 12015-05-27
02 12015-05-20
03 12014-05-16
04 12014-04-04
05 12013-12-18
06 12012-10-16
07 22012-09-27
08 22012-09-20
09 12012-04-26
10 12011-02-17
11 22011-02-15
12 22011-02-10
13 12010-06-25
01 9Mannheim
02 8Penzberg
01 17DE
District Decision : No Action Indicated
Inspection End Date : 2012-09-20
City : Penzberg
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Project Evaluation: Devices
District Decision : No Action Indicated
Inspection End Date : 2012-09-20
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-04-26
City : Mannheim
State :
Country/Area : DE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-04-26
District Decision : No Action Indicated
Inspection End Date : 2012-09-27
City : Mannheim
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2012-09-27
District Decision : No Action Indicated
Inspection End Date : 2012-09-20
City : Penzberg
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2012-09-20
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-25
City : Penzberg
State :
Country/Area : DE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-25
District Decision : No Action Indicated
Inspection End Date : 2011-02-10
City : Penzberg
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2011-02-10
District Decision : No Action Indicated
Inspection End Date : 2011-02-10
City : Penzberg
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Project Evaluation: Devices
District Decision : No Action Indicated
Inspection End Date : 2011-02-10
District Decision : No Action Indicated
Inspection End Date : 2011-02-15
City : Mannheim
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2011-02-15
District Decision : No Action Indicated
Inspection End Date : 2011-02-15
City : Mannheim
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Project Evaluation: Devices
District Decision : No Action Indicated
Inspection End Date : 2011-02-15
District Decision : No Action Indicated
Inspection End Date : 2011-02-17
City : Mannheim
State :
Country/Area : DE
Zip :
District : ORA
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2011-02-17
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