FDA inspection
Novel Laboratories, Inc. d.b.a Lupin Somerset: FDA inspection ending Nov 5, 2020
FDA inspection 1133661 · Official Action Indicated (OAI) · Somerset, NJ
Key facts
| Inspection ID | 1133661 |
|---|---|
| Firm | Novel Laboratories, Inc. d.b.a Lupin Somerset |
| FEI number | 3006271438 |
| Address | 400 Campus Dr |
| City | Somerset |
| State | NJ |
| ZIP | 08873 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Nov 5, 2020 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 613385 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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