FDA inspection
Parks Medical Electronics, Inc: FDA inspection ending Aug 17, 2012
FDA inspection 794391 · Official Action Indicated (OAI) · Aloha, OR
Key facts
| Inspection ID | 794391 |
|---|---|
| Firm | Parks Medical Electronics, Inc |
| FEI number | 3020115 |
| Address | 19460 SW Shaw St |
| City | Aloha |
| State | OR |
| ZIP | 97078 |
| Country | United States |
| Fiscal year | 2012 |
| Inspection end date | Aug 17, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 359639 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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