Roche Diagnostics GmbH - VAI
FDA Inspections Database

Roche Diagnostics GmbH - VAI

FDA Inspections Database

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

VAI · Voluntary Action Indicated Germany
  • Total Records 11
  • Latest Inspection 2025-05-22
  • Data Source U.S. FDA
  • Last Updated -

29

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18

NAI
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11

VAI
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Company Overview

Company

Roche Diagnostics GmbH - VAI

Country

Germany

Website

Visit Website

Email

Social Profiles

LinkedIn
Company Snapshot

Roche Diagnostics GmbH - VAI

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

Germany

www.roche.com/ View on Map
FDA Inspections Timeline (11 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

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

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

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
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

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

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Classification Breakdown
11 total
  • VAI (Voluntary Action Indicated)
Official Source

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

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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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