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.
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.