FDA inspection
Octapharma: FDA inspection ending Apr 8, 2019
FDA inspection 1092062 · Voluntary Action Indicated (VAI) · Lingolsheim
Key facts
| Inspection ID | 1092062 |
|---|---|
| Firm | Octapharma |
| FEI number | 3010600159 |
| Address | 72 Rue Du Marechal Foch |
| City | Lingolsheim |
| Fiscal year | 2019 |
| Inspection end date | Apr 8, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human 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Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data