FDA inspection
LOTTE Biologics USA, LLC: FDA inspection ending Jun 5, 2019
FDA inspection 1093554 · Voluntary Action Indicated (VAI) · East Syracuse, NY
Key facts
| Inspection ID | 1093554 |
|---|---|
| Firm | LOTTE Biologics USA, LLC |
| FEI number | 1317757 |
| Address | 6000 Thompson Rd |
| City | East Syracuse |
| State | NY |
| ZIP | 13057 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Jun 5, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No 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