Company
United StatesAlpha Orthopedic Systems, LLC, Louisville, KY – FDA Inspections
Inspection records and compliance data for Alpha Orthopedic Systems, LLC in Louisville, Kentucky. 4 FDA inspections on record, last inspected April 29, 2024.
Company Profile
This profile covers Alpha Orthopedic Systems, LLC based in Louisville, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected May 21, 2015. Last inspected April 29, 2024.
Most cited issue areas
- Documentation of maintenance and cleaning1 inspection
- Storage temperatures recorded, maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2024 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1237440 |
| April 16, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1088137 |
| February 13, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 999900 |
| May 21, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 929378 |
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
Alpha Orthopedic Systems, LLC
FEI Number
3010292869
Address
12401 Plantside Dr, Louisville, Kentucky 40299, United States
Country
United States
ID: 69a91566-96a9-4cc2-8caf-9ef3a8981171