# FDA 483 - IDT Biologika GmbH - September 08, 2023

Source: https://www.keypedia.com/records/483/idt-biologika-gmbh/8da1b863-9819-406c-ae14-f4ceccec42c6

> 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: Food and Drug Administration
- Summary: The FDA conducted an inspection of IDT Biologika GmbH, a vaccine manufacturer in Dessau-Rosslau, Germany, from August 31 to September 8, 2023. This FDA Form 483 report outlines significant observations indicating potential deviations from Good Manufacturing Practices (GMP) as per the Federal Food, Drug and Cosmetic Act. Primary issues include the release of licensed products prior to the completion of all required conformity tests, specifically concerning an assay where evidence of an application supplement was missing. Environmental monitoring in critical processing areas was deemed inadequate, with specific sampling points failing to effectively capture environmental conditions during production. Additionally, the suitability of testing methods was not adequately verified under actual use, and the Quality Control microbiology lab exhibited deficiencies in reviewing environmental monitoring data, raising concerns about the accuracy and reliability of results due to workspace constraints, potential for mix-ups, and inadequate tools. Further observations highlighted insufficient continuous GMP training and a lack of systematic monitoring for training effectiveness, evidenced by numerous deviations over three years. Finally, the firm's backup data systems were found lacking assurance for data integrity, as audits by the Quality Unit and IT staff were insufficient. IDT Biologika GmbH is expected to address these observations by implementing comprehensive corrective and preventive actions and submitting a response to the FDA.

## Related Documents

- [EIR - 2012-10-18](https://www.keypedia.com/records/eir/idt-biologika-gmbh/4c1191fa-3658-403b-856b-4c4cbc4aaaed)
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- [483 - 2023-09-08](https://www.keypedia.com/records/483/idt-biologika-gmbh/b3d71bf3-6af8-4d68-a1db-17359c22cd11)

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