Company
United StatesOnkos Surgical, Inc., Parsippany, NJ – FDA Inspections
Inspection records and compliance data for Onkos Surgical, Inc. in Parsippany, New Jersey. 4 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected April 04, 2025.
Company Profile
This profile covers Onkos Surgical, Inc. based in Parsippany, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected June 7, 2017. Last inspected April 4, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
- Nonconforming product control1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 4, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1265813 |
| April 8, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1167272 |
| December 10, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1123236 |
| June 7, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1022148 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Onkos Surgical, Inc.
FEI Number
3013450937
Address
77 E Halsey Rd, Parsippany, New Jersey 07054, United States
Country
United States
ID: dac92209-0126-41d3-a023-94ec8e29b4e4