FDA inspection
Sterigenics US, LLC: FDA inspection ending Aug 18, 2023
FDA inspection 1215620 · Voluntary Action Indicated (VAI) · Hayward, CA
Key facts
| Inspection ID | 1215620 |
|---|---|
| Firm | Sterigenics US, LLC |
| FEI number | 3000215205 |
| Address | 2311 Lincoln Ave |
| City | Hayward |
| State | CA |
| ZIP | 94545-1117 |
| Fiscal year | 2023 |
| Inspection end date | Aug 18, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Medical Devices |
| Product type | Devices |
At a glance
- None 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