Company
United StatesPublic company, NASDAQ: AMRXAmneal Pharmaceuticals Inc. (NASDAQ: AMRX), Brookhaven, NY – FDA Inspections
Inspection records and compliance data for Amneal Pharmaceuticals Inc. in Brookhaven, New York. 16 FDA inspections on record, 4 Form 483s, last inspected September 25, 2026. Publicly traded as NASDAQ: AMRX.
Company Profile
This profile covers Amneal Pharmaceuticals Inc. based in Brookhaven, New York, United States.
FDA Inspection History
- FDA inspections
- 16
- OAI
- 0
- VAI
- 7
- NAI
- 7
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 0
First inspected June 22, 2009. Last inspected September 25, 2026.
Most cited issue areas
- Procedures not in writing, fully followed4 inspections
- Calibration/Inspection/Checking not done2 inspections
- Written procedures not established/followed2 inspections
FDA inspections (16)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2026 | Not classified | Human Drugs | 1305048 |
| August 28, 2026 | Not classified | Human Drugs | 1286562 |
| June 7, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1207398 |
| December 20, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1116040 |
| April 18, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1089916 |
| January 30, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1077700 |
| July 10, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1065634 |
| January 18, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1037898 |
| May 24, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1021115 |
| May 16, 2014 | VAI | Human Drugs · Drug Quality Assurance | 881635 |
| July 3, 2013 | VAI | Human Drugs · Drug Quality Assurance | 840485 |
| July 3, 2012 | NAI | Human Drugs · Drug Quality Assurance | 789281 |
| March 10, 2011 | NAI | Human Drugs · Drug Quality Assurance | 714456 |
| August 5, 2010 | NAI | Human Drugs · Drug Quality Assurance | 674757 |
| February 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 642633 |
| June 22, 2009 | VAI | Human Drugs · Drug Quality Assurance | 593733 |
FDA documents
Form 483s (1)
Other FDA documents (1)
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Company Information
Name
Amneal Pharmaceuticals Inc.
Stock ticker
AMRX
Exchange
NASDAQ
Share price
$21.70
Market cap
$7.6B
Price as of
November 13, 2026
FEI Number
3005263655
Address
50 Horseblock Rd, Brookhaven, New York 11719, United States
Country
United States
ID: fd9a56cf-8f99-4c9d-99b2-7bca86ec70eb