Company
United StatesOsteomed, LLC, Addison, TX – FDA Inspections
Inspection records and compliance data for Osteomed, LLC in Addison, Texas. 7 FDA inspections on record, 1 Form 483, last inspected August 08, 2025.
Company Profile
This profile covers Osteomed, LLC based in Addison, Texas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Form 483s
- 1
- Warning letters
- 0
First inspected May 1, 2013. Last inspected August 8, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1278352 |
| August 16, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1232268 |
| August 28, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1217195 |
| September 22, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1026378 |
| January 7, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 955878 |
| February 28, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 868667 |
| May 1, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 829633 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Osteomed, LLC
FEI Number
2027754
Address
3885 Arapaho Rd, Addison, Texas 75001, United States
Country
United States
ID: 4b0582e3-14ed-4c50-b81e-eddb941a5531