FDA inspection
Alpha Orthopedic Systems, LLC: FDA inspection ending Apr 29, 2024
FDA inspection 1237440 · Voluntary Action Indicated (VAI) · Louisville, KY
Key facts
| Inspection ID | 1237440 |
|---|---|
| Firm | Alpha Orthopedic Systems, LLC |
| FEI number | 3010292869 |
| Address | 12401 Plantside Dr |
| City | Louisville |
| State | KY |
| ZIP | 40299 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Apr 29, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data