FDA inspection
ENDO USA, Inc.: FDA inspection ending Jun 5, 2025
FDA inspection 1256071 · Rochester, MI
Key facts
| Inspection ID | 1256071 |
|---|---|
| Firm | ENDO USA, Inc. |
| FEI number | 1818977 |
| Address | 870 Parkdale Rd |
| City | Rochester |
| State | MI |
| ZIP | 48307-1740 |
| Fiscal year | 2025 |
| Inspection end date | Jun 5, 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|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products|New Drug Evaluation|Vaccine, Allergenic, and Live Biotherapeutic Products |
| Product type | Biologics, 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