FDA inspection
Irisys, LLC: FDA inspection ending Apr 7, 2021
FDA inspection 1139694 · Official Action Indicated (OAI) · San Diego, CA
Key facts
| Inspection ID | 1139694 |
|---|---|
| Firm | Irisys, LLC |
| FEI number | 3003600362 |
| Address | 6828 Nancy Ridge Dr Ste 100 |
| City | San Diego |
| State | CA |
| ZIP | 92121-2224 |
| Fiscal year | 2021 |
| Inspection end date | Apr 7, 2021 |
| Classification | Official Action Indicated (OAI) |
| 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