FDA inspection
Pentax of America Inc: FDA inspection ending Aug 16, 2001
FDA inspection 92403 · Voluntary Action Indicated (VAI) · Montvale, NJ
Key facts
| Inspection ID | 92403 |
|---|---|
| Firm | Pentax of America Inc |
| FEI number | 1000080301 |
| Address | 3 Paragon Dr |
| City | Montvale |
| State | NJ |
| ZIP | 07645-1782 |
| Fiscal year | 2001 |
| Inspection end date | Aug 16, 2001 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Med Devices |
| Product type | Devices |
At a glance
- None 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