FDA inspection
Alpha Medical Instruments, LLC: FDA inspection ending Aug 14, 2014
FDA inspection 890488 · Official Action Indicated (OAI) · Mission Viejo, CA
Key facts
| Inspection ID | 890488 |
|---|---|
| Firm | Alpha Medical Instruments, LLC |
| FEI number | 3003289723 |
| Address | 23455 Madero Ste B |
| City | Mission Viejo |
| State | CA |
| ZIP | 92691 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Aug 14, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 441304 |
At a glance
- 1–9 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