Prime Enterprises Inc | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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PRIME ENTERPRISES INC
FDA

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

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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PRIME ENTERPRISES INC

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CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow

FINISHED DOSAGE FORMULATIONS

72 FDF Dossiers, 72 Canada

72 FDF Dossiers
72 Canada

INSPECTIONS & REGISTRATIONS

8 FDA

8 FDA

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FILTER :

filter Legal Name Reset all filters

8 All

01 1PRIME MATTER LABS WEST LLC

02 7Prime Enterprises LLC dba Prime Matter Labs

filter District Decision Reset all filters

8 All

01 1No Action Indicated

02 7Voluntary Action Indicated

filter Inspection End Date Reset all filters

8 All

01 12023-09-01

02 12022-08-25

03 12018-06-13

04 22015-06-08

05 12013-01-03

06 22009-07-13

filter City Reset all filters

8 All

01 7Hialeah

02 1Torrance

filter Country/Area Reset all filters

8 All

01 8U.S.A

Supplier Virtual Booth

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01

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2023-09-01

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-01

Product
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Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2022-08-25

PRIME ENTERPRISES INC

City : Torrance

State : California

Country/Area : U.S.A

Zip : 90502

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-08-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2018-06-13

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2018-06-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2015-06-08

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-06-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2015-06-08

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Unapproved and Misbranded Drugs

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-06-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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06

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2013-01-03

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-01-03

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2009-07-13

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-07-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

PCHi

Not Confirmed

FDA Audited

USA

PCHi

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 : 2009-07-13

PRIME ENTERPRISES INC

City : Hialeah

State : Florida

Country/Area : U.S.A

Zip : 33014

District :

Center :

Project Area : Unapproved and Misbranded Drugs

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-07-13

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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