FDA inspection
Advanced Sterilization Products: FDA inspection ending Sep 28, 2009
FDA inspection 616347 · Official Action Indicated (OAI) · Irvine, CA
Key facts
| Inspection ID | 616347 |
|---|---|
| Firm | Advanced Sterilization Products |
| FEI number | 3003662624 |
| Address | 33 Technology Dr |
| City | Irvine |
| State | CA |
| ZIP | 92618 |
| Country | United States |
| Fiscal year | 2009 |
| Inspection end date | Sep 28, 2009 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 82084 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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