FDA inspection
Sterigenics US LLC: FDA inspection ending Apr 26, 2017
FDA inspection 1009920 · Voluntary Action Indicated (VAI) · Lewis Center, OH
Key facts
| Inspection ID | 1009920 |
|---|---|
| Firm | Sterigenics US LLC |
| FEI number | 1526534 |
| Address | 305 Enterprise Dr |
| City | Lewis Center |
| State | OH |
| ZIP | 43035 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Apr 26, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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
- 10–99 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