Overview

Alfasigma S.p.A. is a leading Italian pharmaceutical company focused on research, development, and commercialization of prescription and over-the-counter medications. It is known for a strong focus on gastroenterology, vascular health, and neurosciences.

Core services & business areas

Cold ChainRegulatory AffairsClinical TrialsContract ManufacturingSupply Chain ManagementMarketing ServicesDistribution

Therapeutic areas

FDA compliance signals

7 FDA enforcement records linked to this company.

  • 4832015-11-10

    Following/documenting laboratory controls

  • 4832015-11-10

    Environmental Monitoring System

  • 4832015-11-10

    Procedures for non-sterile drug products

  • 4832015-11-10

    Absence of Written Procedures

  • 4832015-11-10

    Clothing appropriate for duties performed

  • 4832015-11-10

    Validation lacking for sterile drug products

  • 4832015-11-10

    Instruments, apparatus, et. al. not meeting specs

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