FDA inspection
Organogenesis, Inc.: FDA inspection ending Aug 29, 2025
FDA inspection 1273250 · Canton, MA
Key facts
| Inspection ID | 1273250 |
|---|---|
| Firm | Organogenesis, Inc. |
| FEI number | 1000148471 |
| Address | 150, 65 & 85 Dan Rd |
| City | Canton |
| State | MA |
| ZIP | 02021 |
| Fiscal year | 2025 |
| Inspection end date | Aug 29, 2025 |
| Project area | Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|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
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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