FDA inspection
RoyalVibe Health Ltd.: FDA inspection ending Jul 5, 2022
FDA inspection 1174638 · Official Action Indicated (OAI) · The Woodlands, TX
Key facts
| Inspection ID | 1174638 |
|---|---|
| Firm | RoyalVibe Health Ltd. |
| FEI number | 3022074304 |
| Address | 1095 Evergreen Cir Ste 200 |
| City | The Woodlands |
| State | TX |
| ZIP | 77380 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Jul 5, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 639553 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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