FDA Inspection
Octapharma S.A.S.Octapharma S.A.S. – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Octapharma S.A.S., with an inspection on September 25, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 54fce8f8-3b37-474d-8985-df0f1f8c15e3
Inspection Facts
- Inspection number
- 1337368
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 600.14(c)When to report
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Other FDA inspections of Octapharma S.A.S.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | Office of Inspections and Investigations | |
| December 6, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 8, 2019 | Not classified | Office of Inspections and Investigations | |
| May 25, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Octapharma S.A.S.
- FDA Inspection 1297752 - 2025-11-14
- FDA Inspection 1192276 - 2022-12-06
- FDA Inspection 1092062 - 2019-04-08
- FDA Inspection 1053918 - 2018-05-25
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