Company
United StatesViscot Medical LLC, East Hanover, NJ – FDA Inspections
Inspection records and compliance data for Viscot Medical LLC in East Hanover, New Jersey. 5 FDA inspections on record, last inspected March 03, 2025.
Company Profile
This profile covers Viscot Medical LLC based in East Hanover, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected May 16, 2011. Last inspected March 3, 2025.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 3, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1264137 |
| April 20, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1171580 |
| February 27, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1044420 |
| December 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 861699 |
| May 16, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 724636 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Viscot Medical LLC
FEI Number
2242656
Address
32 West St, East Hanover, New Jersey 07936, United States
Country
United States
ID: 91172b66-8d01-4898-9207-4eee8308decf