Shire Human Genetic Therapies, Inc.

Overview

Shire Human Genetic Therapies, Inc. specializes in the development and commercialization of therapies for rare genetic disorders. It operates as a subsidiary of Takeda Pharmaceutical Company Limited, enhancing Takeda's focus on rare diseases through innovative treatments.

Therapeutic areas

FDA compliance signals

8 FDA enforcement records linked to this company.

  • recall — Class I2019-10-02

    Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

  • recall — Class I2019-10-02

    Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

  • recall — Class I2019-10-02

    Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

  • recall — Class I2019-10-02

    Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

  • 4832015-07-15

    Procedures not in writing, fully followed

  • 4832015-07-15

    Training--operations, GMPs, written procedures

  • 4832014-08-06

    Late submission of 15-day report

  • recall — Class I2014-04-30

    Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

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