FDA Inspection
IDT Biologika GmbHIDT Biologika GmbH – FDA Inspection, Dec 9, 2014
Record Details
This FDA Inspection record concerns IDT Biologika GmbH, with an inspection on December 9, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- IDT Biologika GmbH
- Inspection Date
- December 9, 2014
- Product Type
- Drugs
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ID · 0bffaa28-7c06-4ab7-bb45-1536734ac130
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 908908
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| September 8, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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 |
Other documents for IDT Biologika GmbH
- FDA Inspection 1335726 - 2026-09-15
- FDA Inspection 1217129 - 2023-09-08
- FDA Inspection 1277176 - 2023-08-25
- FDA Inspection 1143607 - 2020-09-10
- FDA Inspection 1084145 - 2019-03-08
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