Samsung Bioepis | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Samsung Bioepis

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EVENTS

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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 226 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
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226 News #PharmaBuzz

DEVELOPMENTS

77 Drugs in Development

77 Drugs in Development

FINISHED DOSAGE FORMULATIONS

98 FDF Dossiers, 16 FDA Orange Book, 70 Europe, 12 Canada

98 FDF Dossiers
16 FDA Orange Book
70 Europe
12 Canada

INSPECTIONS & REGISTRATIONS

6 FDA

6 FDA

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filter Legal Name Reset all filters

6 All

01 1Samsung Bioepis Co., Ltd

02 5Samsung Bioepis Co., Ltd.

filter District Decision Reset all filters

6 All

01 2No Action Indicated

02 4Voluntary Action Indicated

filter Inspection End Date Reset all filters

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01 12024-11-22

02 22023-09-15

03 12019-02-15

04 12018-04-06

05 12016-08-19

filter City Reset all filters

6 All

01 1Suwon

02 5Yeonsu

filter Country/Area Reset all filters

6 All

01 6South Korea

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01

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2024-11-22

Samsung Bioepis

City : Yeonsu

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-11-22

Product
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02

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-15

Samsung Bioepis

City : Yeonsu

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-15

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03

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-15

Samsung Bioepis

City : Yeonsu

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-15

Product
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04

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

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District Decision : No Action Indicated

Inspection End Date : 2019-02-15

Samsung Bioepis

City : Yeonsu

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2019-02-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2018-04-06

Samsung Bioepis

City : Suwon

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2018-04-06

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06

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2016-08-19

Samsung Bioepis

City : Yeonsu

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-08-19

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