Company
United StatesAmneal Pharmaceuticals of New York, LLC, Hauppauge, NY – FDA Inspections
Inspection records and compliance data for Amneal Pharmaceuticals of New York, LLC in Hauppauge, New York. 11 FDA inspections on record, 2 Form 483s, last inspected February 03, 2020.
Company Profile
This profile covers Amneal Pharmaceuticals of New York, LLC based in Hauppauge, New York, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 7
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected August 18, 2009. Last inspected February 3, 2020.
Most cited issue areas
- Clothing appropriate for duties performed1 inspection
- Complaint Handling Procedure1 inspection
- Contamination, chemical or physical change, deterioration1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 3, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1118990 |
| March 18, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1082937 |
| April 11, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1007417 |
| August 9, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 982074 |
| March 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 918318 |
| February 7, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 865012 |
| May 15, 2012 | VAI | Human Drugs · Drug Quality Assurance | 781758 |
| October 29, 2010 | NAI | Human Drugs · Drug Quality Assurance | 697717 |
| May 26, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 664174 |
| November 24, 2009 | VAI | Human Drugs · Drug Quality Assurance | 630090 |
| August 18, 2009 | VAI | Human Drugs · Drug Quality Assurance | 608517 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amneal Pharmaceuticals of New York, LLC
FEI Number
2434153
Address
75 Adams Ave, Hauppauge, New York 11788, United States
Country
United States
ID: 5fccf191-b139-4eb8-98a1-7e6954253cd1