Company
United StatesHowmedica Osteonics Corp., Mahwah, NJ – FDA Inspections
Inspection records and compliance data for Howmedica Osteonics Corp. in Mahwah, New Jersey. 7 FDA inspections on record, 1 Form 483, last inspected December 01, 2023.
Company Profile
This profile covers Howmedica Osteonics Corp. based in Mahwah, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 19, 2009. Last inspected December 1, 2023.
Most cited issue areas
- Investigation of device failures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
- Report of risk to health1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1223869 |
| June 22, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1147430 |
| March 9, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 918064 |
| April 16, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830554 |
| January 15, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 644241 |
| July 20, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 598332 |
| June 19, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 596508 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Howmedica Osteonics Corp.
FEI Number
3003070421
Address
325 Corporate Dr, Mahwah, New Jersey 07430, United States
Country
United States
ID: 6d54b7ca-0e29-4587-878e-94afc700f54c