FDA Inspection
IDT Biologika GmbHIDT Biologika GmbH – FDA Inspection, Sep 8, 2023
Record Details
This FDA Inspection record concerns IDT Biologika GmbH, with an inspection on September 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8997e9f6-413b-4374-a5b9-a5ee8e05cb0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217129
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 610.1Tests prior to release
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 610.1Tests prior to release
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Other FDA inspections of IDT Biologika GmbH
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2026 | Not classified | Office of Inspections and Investigations | Human Cellular, Tissue, and Gene Therapies |
| August 25, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2019 | Not classified | Office of Inspections and Investigations | |
| November 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for IDT Biologika GmbH
- FDA Inspection 1335726 - 2026-09-15
- FDA Inspection 1277176 - 2023-08-25
- FDA Inspection 1143607 - 2020-09-10
- FDA Inspection 1084145 - 2019-03-08
- FDA Inspection 994505 - 2016-11-22
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