Company
United StatesInvaGen Pharmaceuticals, Inc., Hauppauge, NY – FDA Inspections
Inspection records and compliance data for InvaGen Pharmaceuticals, Inc. in Hauppauge, New York. 17 FDA inspections on record, 3 Form 483s, last inspected February 09, 2026.
Company Profile
This profile covers InvaGen Pharmaceuticals, Inc. based in Hauppauge, New York, United States.
FDA Inspection History
- FDA inspections
- 17
- OAI
- 0
- VAI
- 13
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected May 12, 2009. Last inspected February 9, 2026.
Most cited issue areas
- Procedures not in writing, fully followed5 inspections
- Failure to meet specifications3 inspections
- Investigations of discrepancies, failures2 inspections
FDA inspections (17)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2026 | Not classified | Human Drugs · Generic Drug Evaluation | 1302076 |
| October 25, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1223321 |
| December 6, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1111971 |
| May 25, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1053263 |
| March 30, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1007073 |
| April 20, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 970802 |
| May 26, 2015 | VAI | Human Drugs · Drug Quality Assurance | 926606 |
| March 13, 2015 | VAI | Human Drugs · Drug Quality Assurance | 917130 |
| March 8, 2013 | VAI | Human Drugs · Drug Quality Assurance | 821197 |
| June 14, 2012 | VAI | Human Drugs · Drug Quality Assurance | 785889 |
| March 2, 2012 | VAI | Human Drugs · Drug Quality Assurance | 771378 |
| August 12, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 738727 |
| April 13, 2011 | VAI | Human Drugs · Drug Quality Assurance | 718693 |
| November 10, 2010 | VAI | Human Drugs · Drug Quality Assurance | 697223 |
| August 27, 2010 | VAI | Human Drugs · Drug Quality Assurance | 677232 |
| February 19, 2010 | VAI | Human Drugs · Drug Quality Assurance | 640167 |
| May 12, 2009 | VAI | Human Drugs · Drug Quality Assurance | 579549 |
FDA documents
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Company Information
Name
InvaGen Pharmaceuticals, Inc.
FEI Number
3003950641
Address
7 Oser Ave, Hauppauge, New York 11788, United States
Country
United States
ID: 8841516b-25bb-463f-9666-11b69458c306