Company
United StatesInnogenix, LLC. - Inspection Records
Inspection records and compliance data for Innogenix, LLC. in Amityville, New York. 3 FDA inspections on record, 1 Form 483, last inspected March 13, 2025.
Company Profile
This profile covers Innogenix, LLC. based in Amityville, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 14, 2018. Last inspected March 13, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Backup data not assured as exact and complete1 inspection
- Computer control of master formula records1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 15, 2024 | VAI | New York District Office | Drug Quality Assurance |
| May 14, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (8)
FDA Inspection 1265322 - Innogenix, LLC. - 2025-03-13
fda_inspection
FDA Inspection 1265322 - Innogenix, LLC. - 2025-03-13
fda_inspection
483 - Innogenix, LLC. - 2024-11-15
483
483 - Innogenix, LLC. - 2024-11-15
483
FDA Inspection 1255158 - Innogenix, LLC. - 2024-11-15
fda_inspection
FDA Inspection 1255158 - Innogenix, LLC. - 2024-11-15
fda_inspection
EIR - Innogenix, LLC. - 2018-05-14
EIR
FDA Inspection 1054753 - Innogenix, LLC. - 2018-05-14
fda_inspection
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Name
Innogenix, LLC.
FEI Number
3013326213
State
New York
City
Amityville
ID: 0b066751-6110-474e-8c0e-cfa7821c4360