Roche Diagnostics GmbH
FDA Inspections Database

Roche Diagnostics GmbH

FDA Inspections Database

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

VAI · Voluntary Action IndicatedNAI · No Action Indicated Germany
  • Total Records 29
  • Latest Inspection 2025-05-22
  • Data Source U.S. FDA
  • Last Updated -

29

All
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18

NAI
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11

VAI
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Company Overview

Company

Roche Diagnostics GmbH

Country

Germany

Website

Visit Website

Email

Social Profiles

LinkedIn
Company Snapshot

Roche Diagnostics GmbH

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

Germany

www.roche.com/ View on Map
FDA Inspections Timeline (29 records)
2025
22 May
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2025-05-22

FMD Date

-

Fiscal Year

2025

State

Penzberg, Germany

Additional Details

Mutual Recognition Agreement (MRA)

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2025
Citations: No

2021
29 Oct
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2021-10-29

FMD Date

-

Fiscal Year

2022

State

Mannheim, Germany

Additional Details

Mutual Recognition Agreement (MRA)

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2022
Citations: No

2020
16 Sep
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2020-09-16

FMD Date

2021-04-07

Fiscal Year

2020

State

Penzberg, Germany

Additional Details

Mutual Recognition Agreement (MRA)

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2020
Citations: No

2019
29 Aug
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2019-08-29

FMD Date

-

Fiscal Year

2019

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2019
Citations: No

2019
29 Aug
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Postmarket Assurance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2019-08-29

FMD Date

-

Fiscal Year

2019

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2019
Citations: No

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
29 Apr
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-04-29

FMD Date

2016-08-29

Fiscal Year

2016

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2016
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

2014
16 May
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-05-16

FMD Date

2014-08-07

Fiscal Year

2014

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2014
Citations: No

2014
04 Apr
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2014-04-04

FMD Date

2014-10-23

Fiscal Year

2014

State

Mannheim, Germany

Location

Mannheim, , Germany

Inspection Info

Fiscal Year: 2014
Citations: Yes

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
16 Oct
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-10-16

FMD Date

2013-03-28

Fiscal Year

2013

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2013
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

2012
26 Apr
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-04-26

FMD Date

-

Fiscal Year

2012

State

Mannheim, Germany

Location

Mannheim, , 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

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

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

2010
25 Jun
Voluntary Action Indicated VAI

Legal Name

Roche Diagnostics GmbH

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-06-25

FMD Date

2011-02-17

Fiscal Year

2010

State

Penzberg, Germany

Location

Penzberg, , Germany

Inspection Info

Fiscal Year: 2010
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

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Classification Breakdown
29 total
  • VAI (Voluntary Action Indicated)
  • 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

Penzberg, , Germany

Inspection Info

Fiscal Year: 2025
Citations: No

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

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