Company
United StatesExtremity Medical, LLC, Parsippany, NJ – FDA Inspections
Inspection records and compliance data for Extremity Medical, LLC in Parsippany, New Jersey. 5 FDA inspections on record (1 OAI), 1 warning letter, last inspected May 20, 2024.
Company Profile
This profile covers Extremity Medical, LLC based in Parsippany, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 1
First inspected October 24, 2011. Last inspected May 20, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1243318 |
| October 17, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1108440 |
| May 24, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 983658 |
| October 9, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 803969 |
| October 24, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 747120 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Extremity Medical, LLC
FEI Number
3007289093
Address
300 Interpace Pkwy Ste A Fl 2, Parsippany, New Jersey 07054, United States
Country
United States
ID: d2e86374-84d5-4900-ae88-b4e3a85f099d