Baxalta Incorporated

Overview

Baxalta Incorporated was a biopharmaceutical company that focused on developing and delivering therapies for orphan diseases and underserved conditions. It is now part of Shire, which was acquired by Takeda Pharmaceutical Company. Baxalta specialized in hematology, immunology, and oncology.

Therapeutic areas

FDA compliance signals

5 FDA enforcement records linked to this company.

  • 4832022-09-15

    Microbiological Contamination Exam

  • 4832022-09-15

    Establish reliability of supplier's C of A

  • 4832022-09-15

    Investigations of discrepancies, failures

  • 4832022-04-07

    Extent of discrepancy, failure investigations

  • 4832022-04-07

    Validation lacking for sterile drug products

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