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FDA Consent Decree Whacks Shamrock Medical Solutions Group

    https://www.biospace.com/article/releases/fda-consent-decree-whacks-b-shamrock-medical-solutions-group-b-/
    Shamrock Medical repackages and distributes solid and liquid oral non-sterile drug products for human use to hospitals throughout the country. Recent FDA …

Judge Approves Consent Decree Against Shamrock Medical …

    https://www.biopharminternational.com/view/judge-approves-consent-decree-against-shamrock-medical-solutions-group
    Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices. CONTINUE TO …

Drugs mislabeled after Shamrock ignored FDA | Fierce Pharma

    https://www.fiercepharma.com/regulatory/drugs-mislabeled-after-shamrock-ignored-fda
    Not following through to fix problems noted by FDA inspectors is sure to land manfuacturers in trouble with the FDA, and contract manufacturer Shamrock Medical Solutions has …

Drugs From Shamrock Medical Solutions May Be …

    https://www.medscape.com/viewarticle/782414
    Drugs distributed by Shamrock Medical Solutions, in Lewis Center, Ohio, may be mislabeled, the US Food and Drug Administration (FDA) warned today. The FDA …

Labeling Mix-Ups Lead to Consent Decree for Shamrock Medical

    https://www.fdanews.com/articles/158914-labeling-mix-ups-lead-to-consent-decree-for-shamrock-medical
    Shamrock Medical Solutions Group has been barred from any continued drug repackaging and distribution services until it comes into compliance with current good …

FDA Hits Drug Repackager With Mislabeling Suit - Law360

    https://www.law360.com/articles/451893/fda-hits-drug-repackager-with-mislabeling-suit
    According to the FDA, Shamrock Medical Solutions Group LLC had violated the Food, Drug and Cosmetic Act by failing to correct repeated deficiencies with …

Shamrock Medical Solutions Group FDA 483, Mar 2013 | FDAzilla

    https://fdazilla.com/store/form483/3006359068-20130305
    FDA investigators audited the Shamrock Medical Solutions Group - Lewis Center , OH, United States facility and issued 5 inspectional observations (via FDA 483) …

Shamrock Medical Solutions Group FDA EIR, Mar 2013 | FDAzilla

    https://fdazilla.com/store/eir/3006359068-20130305-EIR
    The U.S. FDA issued inspectional observations to Shamrock Medical Solutions Group during a Mar 2013 inspection of the Lewis Center site. Cart About Blog …

Shamrock Medical Solutions Group FDA EIR, Nov 2007 | FDAzilla

    https://fdazilla.com/store/eir/3006359068-20071119-EIR
    EIR Shamrock Medical Solutions Group Nov 2007 Phillip Pontikos FDA , Christian Witkovskie FDA $595.00 - Available Now FDA investigators audited the …

Shamrock Medical Solutions Group FDA 483 Response, Nov …

    https://fdazilla.com/store/resp483/3006359068-20071119-Response
    483 Response Shamrock Medical Solutions Group Nov 2007 Phillip Pontikos FDA , Christian Witkovskie FDA $119.00 - Available Now FDA investigators audited the …



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