Company
United StatesIngen Orthopedics LLC, Cranbury, NJ – FDA Inspections
Inspection records and compliance data for Ingen Orthopedics LLC in Cranbury, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected May 03, 2023.
Company Profile
This profile covers Ingen Orthopedics LLC based in Cranbury, 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 10, 2009. Last inspected May 3, 2023.
Most cited issue areas
- Documentation1 inspection
- Document review, approval documentation1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 3, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1204331 |
| November 7, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1109069 |
| December 22, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 907860 |
| November 30, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 755099 |
| December 10, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 633822 |
FDA documents
Form 483s (1)
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Company Information
Name
Ingen Orthopedics LLC
FEI Number
3005130928
Address
2650 Us Highway 130 Ste C, Cranbury, New Jersey 08512, United States
Country
United States
ID: 3a5a577e-517d-4f13-87f6-854386e92787