Company
United StatesGenesys Orthopedics Systems, LLC, West Lake Hills, TX – FDA Inspections
Inspection records and compliance data for Genesys Orthopedics Systems, LLC in West Lake Hills, Texas. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 10, 2023.
Company Profile
This profile covers Genesys Orthopedics Systems, LLC based in West Lake Hills, Texas, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected April 2, 2012. Last inspected August 10, 2023.
Most cited issue areas
- Report of risk to health1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 10, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1221419 |
| January 16, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1116370 |
| September 8, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1024529 |
| June 24, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 885278 |
| June 5, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 834819 |
| April 2, 2012 | OAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 773496 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genesys Orthopedics Systems, LLC
FEI Number
3008455034
Address
1250 S Capital Of Texas Hwy Ste 600 Bldg # 3, West Lake Hills, Texas 78746, United States
Country
United States
ID: 4a2e433f-1efa-4082-9c1d-61de05e848e7