FDA inspection
ONY Biotech, Inc.: FDA inspection ending Sep 26, 2024
FDA inspection 1250105 · Official Action Indicated (OAI) · Amherst, NY
Key facts
| Inspection ID | 1250105 |
|---|---|
| Firm | ONY Biotech, Inc. |
| FEI number | 1319086 |
| Address | 1576 Sweet Home Rd |
| City | Amherst |
| State | NY |
| ZIP | 14228 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Sep 26, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 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