FDA inspection
Roche Insulin Delivery Systems Inc.: FDA inspection ending Nov 23, 1999
FDA inspection 5036 · Official Action Indicated (OAI) · Fishers, IN
Key facts
| Inspection ID | 5036 |
|---|---|
| Firm | Roche Insulin Delivery Systems Inc. |
| FEI number | 1000116163 |
| Address | 11800 Exit 5 Pkwy Ste 120 |
| City | Fishers |
| State | IN |
| ZIP | 46037-7989 |
| Fiscal year | 2000 |
| Inspection end date | Nov 23, 1999 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Med Devices |
| Product type | Devices |
At a glance
- None 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