FDA inspection
Respironics, Inc.: FDA inspection ending Feb 14, 2023
FDA inspection 1197512 · Official Action Indicated (OAI) · Mount Pleasant, PA
Key facts
| Inspection ID | 1197512 |
|---|---|
| Firm | Respironics, Inc. |
| FEI number | 3002797442 |
| Address | 174 Tech Center Dr |
| City | Mount Pleasant |
| State | PA |
| ZIP | 15666 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Feb 14, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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