# IDT Biologika GmbH – FDA 483, Sep 8, 2023

Source: https://www.keypedia.com/records/483/idt-biologika-gmbh/b3d71bf3-6af8-4d68-a1db-17359c22cd11

> FDA 483 for IDT Biologika GmbH on September 08, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IDT Biologika GmbH
- Inspection Date: 2023-09-08
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: IDT Biologika GmbH, a vaccine manufacturer in Dessau-Rosslau, Germany, was cited for five significant deficiencies during an FDA inspection. These observations include releasing products before completing required tests, inadequate environmental monitoring, and issues with the suitability and verification of testing methods. Additionally, the firm was found to have deficiencies in its GMP training program and its system for ensuring the integrity and security of backup data.

## Related Documents

- [EIR - 2016-11-22](https://www.keypedia.com/records/eir/idt-biologika-gmbh/6a82494a-ec09-42ea-9443-75e7b99ec69e) — date: November 22, 2016
- [EIR - 2012-10-18](https://www.keypedia.com/records/eir/idt-biologika-gmbh/4c1191fa-3658-403b-856b-4c4cbc4aaaed) — date: October 18, 2012

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Program Division Director](https://www.keypedia.com/people/randy-f-pack/c4e89614-5aa6-4d3f-90dc-68482b499967)
- [President at Genpact](https://www.keypedia.com/people/damon-a-growl/b2827f8c-e454-4db3-9285-07d11b964d5a)

Company: https://www.keypedia.com/companies/idt-biologika-gmbh/ec3af185-e1cd-4ce4-9268-6cbfb25fa986

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321