FDA inspection
Smart World LLC., DBA Steri-Tek: FDA inspection ending Apr 10, 2019
FDA inspection 1085840 · Voluntary Action Indicated (VAI) · Fremont, CA
Key facts
| Inspection ID | 1085840 |
|---|---|
| Firm | Smart World LLC., DBA Steri-Tek |
| FEI number | 3012448339 |
| Address | 48225 Lakeview Blvd |
| City | Fremont |
| State | CA |
| ZIP | 94538-6519 |
| Fiscal year | 2019 |
| Inspection end date | Apr 10, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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