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    Details of Minakem Sas's U.S. FDA Inspections. Original Data: FDA Inspection Database

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    01 Delmar Chemicals, Ltd. (2)

    02 Minakem Beuvry Production SAS (7)

    03 Minakem Dunkerque Production (3)

    04 Minakem High Potent, S.A. (3)

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    01 No Action Indicated (4)

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    07 2013-09-13 (2)

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    09 2012-11-01 (1)

    10 2012-01-12 (1)

    11 2010-07-08 (2)

    12 2009-04-08 (1)

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    01 Beuvry-la-foret (7)

    02 Corbais (3)

    03 Dunkirk (3)

    04 Lasalle (2)

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    01 BE (3)

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    03 FR (10)

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    Voluntary Action Indicated
    2020-02-06
    Corbais
    BE
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    Voluntary Action Indicated
    2018-06-22
    Dunkirk
    FR
    ORA
    CDER
    Drug Quality Assurance
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    CPhI Japan

    Booth #5G-04

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    • FDA
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    Voluntary Action Indicated
    2018-01-25
    Beuvry-la-foret
    FR
    ORA
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    Drug Quality Assurance
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    CPhI Japan

    Booth #5G-04

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    • FDA
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    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    Voluntary Action Indicated
    2016-04-22
    Dunkirk
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

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    • FDA
    • EDQM
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    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    Voluntary Action Indicated
    2016-03-25
    Beuvry-la-foret
    FR
    ORA
    CVM
    Monitoring of Marketed An...
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    CPhI Japan

    Booth #5G-04

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    • FDA
    • EDQM
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    Voluntary Action Indicated
    2016-03-25
    Beuvry-la-foret
    FR
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    No Action Indicated
    2015-09-24
    Corbais
    BE
    ORA
    CDER
    Drug Quality Assurance
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    Virtual Booth Virtual Booth
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    INSPECTIONS & REGISTRATIONS

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    Voluntary Action Indicated
    2013-09-13
    Beuvry-la-foret
    FR
    ORA
    CVM
    Monitoring of Marketed An...
    Minakem Comapny Banner

    CPhI Japan

    Booth #5G-04

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    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids
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    No Action Indicated
    2009-04-08
    Lasalle
    CA
    ORA
    CDER
    Drug Quality Assurance
    Minakem Delmar

    CPhI Japan

    Not Confirmed

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    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids
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    No Action Indicated
    2012-11-01
    Lasalle
    CA
    ORA
    CDER
    Drug Quality Assurance
    Minakem Delmar

    CPhI Japan

    Not Confirmed

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