FDA Inspection
ENDO USA, Inc.ENDO USA, Inc. – FDA Inspection, Jun 5, 2025
Record Details
This FDA Inspection record concerns ENDO USA, Inc., with an inspection on June 5, 2025, issued by the Detroit District Office, covering biologics.
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ID · 319f1250-cfd1-4256-b8bf-1703122dfae3
Inspection Facts
- Inspection number
- 1256071
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of ENDO USA, Inc.
17| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2025 | OAI | Detroit District Office | Drug Quality Assurance |
| April 14, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 15, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 9, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for ENDO USA, Inc.
- FDA Inspection 1287690 - 2025-10-20
- FDA Inspection 1202528 - 2023-04-14
- FDA Inspection 1155650 - 2021-10-22
- FDA Inspection 1086628 - 2019-04-15
- FDA Inspection 1061939 - 2018-08-09
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