FDA Inspection
ENDO USA, Inc.ENDO USA, Inc. – FDA Inspection, Aug 9, 2018
Record Details
This FDA Inspection record concerns ENDO USA, Inc., with an inspection on August 9, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Mihaly S. Ligmond (FDA Associated Person)
- Omotunde O. Osunsanmi (Issuing Officer)
View Company Profile
ID · 4c2ebf02-2f36-43f7-a198-f370296d9f69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061939
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
Other FDA inspections of ENDO USA, Inc.
17| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2025 | OAI | Detroit District Office | Drug Quality Assurance |
| June 5, 2025 | Not classified | Detroit District Office | Blood and Blood Products |
| 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 |
Other documents for ENDO USA, Inc.
- FDA Inspection 1287690 - 2025-10-20
- FDA Inspection 1256071 - 2025-06-05
- FDA Inspection 1202528 - 2023-04-14
- FDA Inspection 1155650 - 2021-10-22
- FDA Inspection 1086628 - 2019-04-15
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