Company
United StatesENDO USA, Inc, Rye, NY – FDA Inspections
Inspection records and compliance data for ENDO USA, Inc in Rye, New York. 9 FDA inspections on record, last inspected September 26, 2025.
Company Profile
This profile covers ENDO USA, Inc based in Rye, New York, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 24, 2009. Last inspected September 26, 2025.
Most cited issue areas
- Failing drug products not rejected1 inspection
- Failure by applicant to report ADE1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2025 | Not classified | Human Drugs | 1288360 |
| March 3, 2021 | NAI | Human Drugs · Drug Quality Assurance | 1136893 |
| January 27, 2016 | NAI | Human Drugs · Drug Quality Assurance | 963017 |
| October 28, 2013 | VAI | Human Drugs · Drug Quality Assurance | 851401 |
| December 7, 2012 | VAI | Human Drugs · Drug Quality Assurance | 809209 |
| January 27, 2012 | NAI | Human Drugs · Drug Quality Assurance | 764681 |
| December 20, 2010 | NAI | Human Drugs · Drug Quality Assurance | 702550 |
| August 17, 2010 | VAI | Human Drugs · Drug Quality Assurance | 676115 |
| November 24, 2009 | NAI | Human Drugs · Drug Quality Assurance | 632336 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ENDO USA, Inc
FEI Number
2410861
Address
70 High St, Rye, New York 10580, United States
Country
United States
ID: f9a78673-fb86-4980-bb89-72259da48fb9