Endo USA, Inc.
Form 483 issued January 17, 2025 · Cranbury, New Jersey
- Inspection
- Jan 7 – Jan 17, 2025
- Investigator
- Ankur C. Patel
- Observations
- 9
- Pages
- 13
- FEI number
- 2243842
In short: On January 17, 2025, FDA issued a Form 483 with 9 observations to Endo USA, Inc. in Cranbury, New Jersey (FEI 2243842) after an inspection that ran Jan 7 – Jan 17, 2025. The investigator was Ankur C. Patel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 03
Page 2 of 13 are reported: 1. Pursuant to Section 71 2. To assist firms insp…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmEndo USA, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Endo USA, Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Endo USA, Inc.?
Ankur C. Patel is named on this Form 483, for the inspection of Jan 7 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Endo USA, Inc. inspected by FDA?
The inspection ran Jan 7 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
How do I get the full Form 483 for Endo USA, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.