FDA Inspection
ENDO USA, Inc.ENDO USA, Inc. – FDA Inspection, Apr 15, 2019
Record Details
This FDA Inspection record concerns ENDO USA, Inc., with an inspection on April 15, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Amy S. Graf (Issuing Officer)
- Joseph T. Madak (Company Rep)
- Sarah E. Rhoades (FDA Associated Person)
- Shirshendu K. Deb (Company Rep)
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ID · eea61f68-2796-48c2-b232-1755a4321ffb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086628
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
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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 |
| 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 |
| 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 1256071 - 2025-06-05
- FDA Inspection 1202528 - 2023-04-14
- FDA Inspection 1155650 - 2021-10-22
- FDA Inspection 1061939 - 2018-08-09
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