Oralabs Inc | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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ORALABS INC
FDA

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-1-m-2026-04-20

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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ORALABS INC

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 1 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
1 News #PharmaBuzz

INSPECTIONS & REGISTRATIONS

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6 FDA

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01 6OraLabs, Incorporated

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01 1No Action Indicated

02 1Official Action Indicated

03 4Voluntary Action Indicated

filter Inspection End Date Reset all filters

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01 12020-01-10

02 12018-07-13

03 12015-12-18

04 12013-06-26

05 12011-11-23

06 12010-08-11

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01 6Parker

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01 6U.S.A

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01

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

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District Decision : Voluntary Action Indicated

Inspection End Date : 2020-01-10

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-01-10

Product
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Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : Voluntary Action Indicated

Inspection End Date : 2018-07-13

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-07-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : Voluntary Action Indicated

Inspection End Date : 2015-12-18

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-12-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : 2013-06-26

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-06-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : Voluntary Action Indicated

Inspection End Date : 2011-11-23

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-11-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

AMWC Asia-TDAC

Not Confirmed

FDA Audited

USA

AMWC Asia-TDAC

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 : Official Action Indicated

Inspection End Date : 2010-08-11

ORALABS INC

City : Parker

State : Colorado

Country/Area : U.S.A

Zip : 80134

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2010-08-11

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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