Company
United StatesHealgen Scientific LLC, Kinderhook, NY – FDA Inspections
Inspection records and compliance data for Healgen Scientific LLC in Kinderhook, New York. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 22, 2018.
Company Profile
This profile covers Healgen Scientific LLC based in Kinderhook, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 25, 2010. Last inspected March 22, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1045915 |
| June 25, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 887242 |
| May 18, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 724997 |
| March 25, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 651057 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Healgen Scientific LLC
FEI Number
3000718556
Address
122 Smith Rd, Kinderhook, New York 12106, United States
Country
United States
ID: 5af14173-bcd4-4ac5-a4ae-83abd0061d77