Overview

Chiesi USA, Inc. is a subsidiary of the Chiesi Group, a global pharmaceutical company operating in the healthcare sector, primarily focused on research, development, and commercialization of innovative therapies. The subsidiary works to support the delivery of medicines that improve the quality of human life.

Therapeutic areas

RespiratoryNeonatologyRare DiseasesTransplant MedicineSpecial Care

FDA compliance signals

6 FDA enforcement records linked to this company.

  • recall — Class II2026-04-01

    Lack of Assurance of Sterility

  • recall — Class II2019-06-19

    Failed Dissolution Specifications: Out of specification result for dissolution.

  • recall — Class II2019-06-19

    Failed Dissolution Specifications: Out of specification result for dissolution.

  • warning_letter2010-06-22

    FDA Warning Letter (drug product)

  • warning_letter2009-11-13

    FDA Warning Letter (drug product)

  • warning_letter2009-05-04

    FDA Warning Letter (drug product)

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