Company
United StatesAmerican Regent, Inc., Shirley, NY – FDA Inspections
Inspection records and compliance data for American Regent, Inc. in Shirley, New York. 13 FDA inspections on record (1 OAI), 2 Form 483s, last inspected April 21, 2026.
Company Profile
This profile covers American Regent, Inc. based in Shirley, New York, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 1
- VAI
- 8
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected December 16, 2008. Last inspected April 21, 2026.
Most cited issue areas
- Investigations of discrepancies, failures4 inspections
- Procedures for sterile drug products4 inspections
- Procedures not in writing, fully followed4 inspections
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2026 | Not classified | Animal Drugs & Feeds · Drug Quality Assurance | 1313930 |
| April 24, 2024 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1236810 |
| November 15, 2019 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1118512 |
| April 11, 2018 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1047853 |
| February 28, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 963173 |
| February 26, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 963315 |
| October 29, 2014 | VAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 901719 |
| March 29, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 767250 |
| March 15, 2011 | OAI | Human Drugs · Drug Quality Assurance | 713642 |
| October 29, 2010 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 695919 |
| October 6, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 695077 |
| November 5, 2009 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 624333 |
| December 16, 2008 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 555024 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
American Regent, Inc.
FEI Number
2410375
Address
5 Ramsay Rd, Shirley, New York 11967, United States
Country
United States
ID: a73360d0-4ea2-40a4-aa12-221cece9173f