IDT Biologika GmbH
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.
Therapeutic areas
FDA compliance signals
26 FDA enforcement records linked to this company.
- 4832023-09-08
Backup data not assured as exact and complete
- 4832023-09-08
GMP Training Frequency
- 4832023-09-08
Environmental Monitoring System
- 4832023-09-08
Suitability of testing methods verified
- 4832016-11-22
Written record of complaint to include findings, follow-up
- 4832016-11-22
Investigations of discrepancies, failures
- 4832016-11-22
Annual visual exams of drug products
- 4832016-11-22
Stability sample storage conditions described
- 4832016-11-22
Establish reliability of supplier's C of A
- 4832016-11-22
Approve or reject procedures or specs
- 4832016-11-22
Testing and release for distribution
- 4832016-11-22
Deviations from laboratory control requirements
- 4832016-11-22
No written record of investigation
- 4832016-11-22
Procedure Deviations Recorded and Justified
- 4832016-11-22
Test methods
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