FDA inspection
Pentax of America Inc: FDA inspection ending Dec 18, 2012
FDA inspection 812553 · Official Action Indicated (OAI) · Montvale, NJ
Key facts
| Inspection ID | 812553 |
|---|---|
| Firm | Pentax of America Inc |
| FEI number | 1000080301 |
| Address | 3 Paragon Dr |
| City | Montvale |
| State | NJ |
| ZIP | 07645 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Dec 18, 2012 |
| 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
- 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