Endo USA, Inc.
FDA inspection history in Rochester, Michigan, 2012 to 2026
- 7
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2012: one Form 483; 2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2021: two Form 483s; 2023: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One Form 483, at Rochester, Michigan.
- 2015–23Six Form 483s, at Rochester, Michigan.
- 2021The longest 483 on file: 4 observations over 3 pages at Rochester, Michigan.
- 2026One warning letter, at Rochester, Michigan.
Cited most
Across all Endo USA observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.188(b)Batch production and control records1
The complete Endo USA file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Rochester, Michigan
Seven Form 483s and one warning letter · 2012 to 2026 · 14 observations
Latest: Warning letter, Apr 15, 2026 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-15 | Warning letter Warning letter | Rochester, Michigan | — | $99 |
| 2023-04-14 | 483 Form 483 | Rochester, Michigan | 1 | $99 |
| 2021-10-22 | 483 Form 483 | Rochester, Michigan | 4 | $99 |
| 2021-07-20 | 483 Form 483 | Rochester, Michigan | 2 | $99 |
| 2019-04-15 | 483 Form 483 | Rochester, Michigan | 1 | $99 |
| 2017-03-13 | 483 Form 483 | Rochester, Michigan | 1 | $99 |
| 2015-07-23 | 483 Form 483 | Rochester, Michigan | 3 | $99 |
| 2012-12-28 | 483 Form 483 | Rochester, Michigan | 2 | $99 |
Investigators on these documents
Emily J. Orban (2)Rebecca E. Dombrowski (2)Emilie Kahn (1)Jacob G. Lutz (1)Joseph A. Piechocki (1)Joseph T. Madak (1)Lauren M. Lilly (1)Michele L. Forster (1)Sarah E. Rhoades (1)Sarah M. Napier (1)Shirshendu K. Deb (1)Amy S. Graf (1)
FEI number 1818977 · most recent document Apr 15, 2026
About Endo USA, Inc.
How many FDA Form 483s has Endo USA, Inc. received?
FDA Intel has 7 Form 483s on file for Endo USA, Inc.; the most recent is dated Apr 14, 2023.
When was Endo USA, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Endo USA, Inc. is a Form 483 dated Apr 14, 2023, for the site in Rochester, Michigan.
What did FDA cite at Endo USA, Inc.?
The regulations cited most in the observations on file for Endo USA, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.
Has Endo USA, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Endo USA, Inc.; the most recent is dated Apr 15, 2026.