FDA Inspection
ENDO USA, Inc.ENDO USA, Inc. – FDA Inspection, Mar 13, 2017
Record Details
This FDA Inspection record concerns ENDO USA, Inc., with an inspection on March 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Bei Y. He
- Emilie Kahn (Issuing Officer)
- Emily J. Stoklosa (Issuing Officer)
View Company Profile
ID · 2c4dd684-78ef-4429-9a96-a5debeaa49e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007400
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.