Company
United StatesFougera Pharmaceuticals, Inc., Hicksville, NY – FDA Inspections
Inspection records and compliance data for Fougera Pharmaceuticals, Inc. in Hicksville, New York. 13 FDA inspections on record, 5 Form 483s, last inspected March 26, 2026.
Company Profile
This profile covers Fougera Pharmaceuticals, Inc. based in Hicksville, New York, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 0
- VAI
- 12
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 5
- Warning letters
- 0
First inspected February 6, 2009. Last inspected March 26, 2026.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance2 inspections
- Absence of Written Procedures1 inspection
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2026 | Not classified | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1309464 |
| November 17, 2023 | VAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1223760 |
| August 10, 2022 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1177371 |
| August 8, 2019 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1099624 |
| May 29, 2018 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1053494 |
| November 10, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 992897 |
| December 23, 2014 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 908065 |
| December 20, 2013 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 857953 |
| November 16, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 807656 |
| February 1, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 765607 |
| February 9, 2011 | VAI | Human Drugs · Drug Quality Assurance | 709476 |
| January 12, 2010 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 636208 |
| February 6, 2009 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 565411 |
FDA documents
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fougera Pharmaceuticals, Inc.
FEI Number
2410271
Address
55 Cantiague Rock Rd, Hicksville, New York 11801, United States
Country
United States
ID: 99a927b0-c274-4af7-ab29-2cb4247754c5