Company
United StatesEnterix, Inc., Edison, NJ – FDA Inspections
Inspection records and compliance data for Enterix, Inc. in Edison, New Jersey. 5 FDA inspections on record, 2 Form 483s, last inspected August 10, 2026.
Company Profile
This profile covers Enterix, Inc. based in Edison, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected July 1, 2010. Last inspected August 10, 2026.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Corrective action not taken1 inspection
- Feedback process procedures not documented1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 10, 2026 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1330540 |
| March 10, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1199942 |
| August 18, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 983532 |
| November 27, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 808178 |
| July 1, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 670927 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Enterix, Inc.
FEI Number
3003224146
Address
236 Fernwood Ave, Edison, New Jersey 08837, United States
Country
United States
ID: f801ccab-bedf-4ec7-ab7e-57d65fed2a66