Roche Diagnostics GmbH - NAI
FDA Inspections Database

Roche Diagnostics GmbH - NAI

FDA Inspections Database

U.S. FDA inspection classifications and citation records from the official FDA inspection database.

NAI · No Action Indicated Germany
  • Total Records 18
  • Latest Inspection 2018-04-19
  • Data Source U.S. FDA
  • Last Updated -

29

All
View

18

NAI
View

11

VAI
View
Company Overview

Company

Roche Diagnostics GmbH - NAI

Country

Germany

Website

Visit Website

Email

Social Profiles

LinkedIn
Company Snapshot

Roche Diagnostics GmbH - NAI

Sandhofer Strasse 116 P.O. Box 310120 Mannheim, 68305

Germany

www.roche.com/ View on Map
FDA Inspections Timeline (18 records)
2018
19 Apr
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2018-04-19

FMD Date

-

Fiscal Year

2018

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2018
Citations: No

2018
12 Apr
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2018-04-12

FMD Date

-

Fiscal Year

2018

State

Penzberg, Germany

Additional Details

Postmarket Audit Inspections

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2018
Citations: No

2018
12 Apr
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2018-04-12

FMD Date

-

Fiscal Year

2018

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2018
Citations: No

2016
18 Nov
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2016-11-18

FMD Date

-

Fiscal Year

2017

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2017
Citations: No

2016
22 Apr
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-04-22

FMD Date

2016-08-24

Fiscal Year

2016

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2016
Citations: No

2015
27 May
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2015-05-27

FMD Date

-

Fiscal Year

2015

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2015
Citations: No

2015
20 May
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2015-05-20

FMD Date

-

Fiscal Year

2015

State

Penzberg, Germany

Additional Details

Postmarket Audit Inspections

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2015
Citations: No

2013
18 Dec
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2013-12-18

FMD Date

-

Fiscal Year

2014

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2014
Citations: No

2012
27 Sep
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2012-09-27

FMD Date

-

Fiscal Year

2012

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2012
Citations: No

2012
27 Sep
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2012-09-27

FMD Date

-

Fiscal Year

2012

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2012
Citations: No

2012
20 Sep
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2012-09-20

FMD Date

-

Fiscal Year

2012

State

Penzberg, Germany

Additional Details

Postmarket Audit Inspections

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2012
Citations: No

2012
20 Sep
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2012-09-20

FMD Date

-

Fiscal Year

2012

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2012
Citations: No

2011
17 Feb
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2011-02-17

FMD Date

-

Fiscal Year

2011

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2011
Citations: No

2011
15 Feb
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2011-02-15

FMD Date

-

Fiscal Year

2011

State

Mannheim, Germany

Additional Details

Postmarket Audit Inspections

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2011
Citations: No

2011
15 Feb
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2011-02-15

FMD Date

-

Fiscal Year

2011

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2011
Citations: No

2011
10 Feb
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2011-02-10

FMD Date

-

Fiscal Year

2011

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2011
Citations: No

2011
10 Feb
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Bioresearch Monitoring

Product Type

Devices

Posted Citations

No

Inspection End Date

2011-02-10

FMD Date

-

Fiscal Year

2011

State

Penzberg, Germany

Additional Details

Postmarket Audit Inspections

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2011
Citations: No

2009
19 Jun
No Action Indicated NAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-06-19

FMD Date

2009-06-12

Fiscal Year

2009

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2009
Citations: No

Related Databases
  • FDA Inspections
    29 View
  • EDQM CEP
    4 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
Classification Breakdown
18 total
  • NAI (No Action Indicated)
Official Source

All data is sourced from the official FDA inspection database maintained by the U.S. Food and Drug Administration.

Visit FDA.gov
Record Details Preview

Click "View Details" on any record above to expand full details inline.

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2018
Citations: No

100% Official Data

Directly from the U.S. FDA inspection database

Regular Updates

Data updated regularly from official sources

Trusted by Professionals

100K+ pharma professionals worldwide

Secure & Reliable

Enterprise-grade security and data protection

FDA inspection data is compiled from publicly available U.S. FDA inspection classification records.

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit