FDA Inspection
ENDO USA, Inc.ENDO USA, Inc. – FDA Inspection, Oct 20, 2025
Record Details
This FDA Inspection record concerns ENDO USA, Inc., with an inspection on October 20, 2025, issued by the Detroit District Office, covering human drugs.
View Company Profile
ID · b5f733a6-5903-4ef1-91da-486952bf0268
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1287690
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ENDO USA, Inc.
17| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 9, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for ENDO USA, Inc.
- FDA Inspection 1256071 - 2025-06-05
- FDA Inspection 1202528 - 2023-04-14
- FDA Inspection 1155650 - 2021-10-22
- FDA Inspection 1086628 - 2019-04-15
- FDA Inspection 1061939 - 2018-08-09
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.