Endo USA, Inc.
FDA inspection history in Cranbury, New Jersey, 2018 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Cranbury, New Jersey.
- 2025One Form 483, at Cranbury, New Jersey.
- 2025The longest 483 on file: 9 observations over 13 pages at Cranbury, New Jersey.
Cited most
Across all Endo USA observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194(a)(4)Laboratory records1
- 21 CFR 211.42(c)(10)(v)Design and construction features1
The complete Endo USA file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cranbury, New Jersey
Two Form 483s · 2018 to 2025 · 14 observations
Latest: Form 483, Jan 17, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-17 | 483 Form 483 | Cranbury, New Jersey | 9 | $99 |
| 2018-10-23 | 483 Form 483 | Cranbury, New Jersey | 5 | $99 |
Investigators on these documents
FEI number 2243842 · most recent document Jan 17, 2025
About Endo USA, Inc.
How many FDA Form 483s has Endo USA, Inc. received?
FDA Intel has 2 Form 483s on file for Endo USA, Inc.; the most recent is dated Jan 17, 2025.
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 Jan 17, 2025, for the site in Cranbury, New Jersey.
What did FDA cite at Endo USA, Inc.?
The regulations cited most in the observations on file for Endo USA, Inc. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.