FDA Inspection
Octapharma Dessau GmbHOctapharma Dessau GmbH – FDA Inspection, Nov 8, 2024
Record Details
This FDA Inspection record concerns Octapharma Dessau GmbH, with an inspection on November 8, 2024, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 447dad7e-f2a8-4462-8b43-bf8279cd8329
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253986
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 600.14(a)(1)Who must report - manufacturer
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Other FDA inspections of Octapharma Dessau GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 18, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Dessau GmbH
- FDA Inspection 1079455 - 2018-11-15
- FDA Inspection 960098 - 2016-02-18
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