Company
United StatesFougera Pharmaceuticals Inc., Melville, NY – FDA Inspections
Inspection records and compliance data for Fougera Pharmaceuticals Inc. in Melville, New York. 12 FDA inspections on record, 2 Form 483s, last inspected December 08, 2023.
Company Profile
This profile covers Fougera Pharmaceuticals Inc. based in Melville, New York, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 11
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 6, 2009. Last inspected December 8, 2023.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance2 inspections
- Scientifically sound laboratory controls2 inspections
- SOPs not followed / documented2 inspections
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2023 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1226533 |
| August 10, 2022 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1177370 |
| August 8, 2019 | VAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1099025 |
| May 29, 2018 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1053495 |
| November 10, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 992924 |
| December 23, 2014 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 908064 |
| October 31, 2013 | VAI | Human Drugs · Drug Quality Assurance | 857676 |
| November 16, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 807660 |
| June 15, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 780240 |
| February 9, 2011 | VAI | Human Drugs · Bioresearch Monitoring | 705760 |
| January 12, 2010 | VAI | Animal Drugs & Feeds, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 636203 |
| February 6, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 565460 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fougera Pharmaceuticals Inc.
FEI Number
2432435
Address
60 Baylis Rd, Melville, New York 11747, United States
Country
United States
ID: 3868bd8e-22c5-4998-85b0-38e0df2d115b