Company
United StatesPublic company, NASDAQ: AMRXAmneal Pharmaceuticals, Llc (NASDAQ: AMRX), Paterson, NJ – FDA Inspections
Inspection records and compliance data for Amneal Pharmaceuticals, Llc in Paterson, New Jersey. 6 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected October 25, 2017. Publicly traded as NASDAQ: AMRX.
Company Profile
This profile covers Amneal Pharmaceuticals, Llc based in Paterson, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected November 10, 2008. Last inspected October 25, 2017.
Most cited issue areas
- Failure to meet specifications2 inspections
- Investigations of discrepancies, failures2 inspections
- Procedures not in writing, fully followed2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1029733 |
| October 13, 2016 | NAI | Human Drugs · Drug Quality Assurance | 989412 |
| November 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 854082 |
| February 10, 2012 | NAI | Human Drugs · Drug Quality Assurance | 767064 |
| May 26, 2010 | VAI | Human Drugs · Drug Quality Assurance | 663872 |
| November 10, 2008 | VAI | Human Drugs · Drug Quality Assurance | 545906 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amneal Pharmaceuticals, Llc
Stock ticker
AMRX
Exchange
NASDAQ
Share price
$21.70
Market cap
$7.6B
Price as of
November 13, 2026
FEI Number
3003792057
Address
209 McLean Blvd, Paterson, New Jersey 07504, United States
Country
United States
ID: 1727fcb2-2120-4a7c-a93b-a52aa106268f