Rommelag Ag | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Rommelag AG
FDA

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Rommelag AG

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INSPECTIONS & REGISTRATIONS

6 FDA

6 FDA

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01 6Rommelag CDMO GmbH

filter District Decision Reset all filters

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01 2No Action Indicated

02 4Voluntary Action Indicated

filter Inspection End Date Reset all filters

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01 12019-09-17

02 12015-10-22

03 12014-02-14

04 12014-02-12

05 12012-02-24

06 12012-02-17

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01 6Sulzbach-Laufen

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01 6Germany

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01

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : No Action Indicated

Inspection End Date : 2019-09-17

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2019-09-17

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02

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2015-10-22

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

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District :

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Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-10-22

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03

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2014-02-14

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

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District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-02-14

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04

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2014-02-12

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-02-12

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05

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2012-02-24

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-02-24

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06

FDA Audited

USA

Arvo

Not Confirmed

FDA Audited

USA

Arvo

Not Confirmed

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District Decision : No Action Indicated

Inspection End Date : 2012-02-17

Rommelag AG

City : Sulzbach-Laufen

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-02-17

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