Company
United StatesHealgen Scientific LLC, Logan Township, NJ – FDA Inspections
Inspection records and compliance data for Healgen Scientific LLC in Logan Township, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected December 08, 2025.
Company Profile
This profile covers Healgen Scientific LLC based in Logan Township, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected December 23, 2010. Last inspected December 8, 2025.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1296424 |
| June 13, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1093192 |
| October 15, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 945550 |
| March 1, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 820050 |
| December 23, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 701533 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Healgen Scientific LLC
FEI Number
3003204823
Address
603 Heron Dr , Ste 4, Logan Township, New Jersey 08085, United States
Country
United States
ID: 9f0da1a5-f165-4618-b86b-c5fa807db2f2