Overview

IDT Biologika GmbH is a privately-held company specializing in the development and production of vaccines, pharmaceuticals, and biologics for human and veterinary use. As a global leader in viral vaccines, IDT Biologika partners with other industry leaders to advance healthcare and improve quality of life.

Core services & business areas

Vaccine ProductionPharmaceutical ManufacturingResearch and DevelopmentClinical TrialsQuality Control

Therapeutic areas

FDA compliance signals

26 FDA enforcement records linked to this company.

  • 4832023-09-08

    Suitability of testing methods verified

  • 4832023-09-08

    Backup data not assured as exact and complete

  • 4832023-09-08

    GMP Training Frequency

  • 4832023-09-08

    Environmental Monitoring System

  • 4832016-11-22

    Complete test data included in records

  • 4832016-11-22

    Test methods

  • 4832016-11-22

    Procedure Deviations Recorded and Justified

  • 4832016-11-22

    No written record of investigation

  • 4832016-11-22

    Deviations from laboratory control requirements

  • 4832016-11-22

    Testing and release for distribution

  • 4832016-11-22

    Approve or reject procedures or specs

  • 4832016-11-22

    Establish reliability of supplier's C of A

  • 4832016-11-22

    Stability sample storage conditions described

  • 4832016-11-22

    Annual visual exams of drug products

  • 4832016-11-22

    Written record of complaint to include findings, follow-up

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