FDA inspection
Prentke Romich Company: FDA inspection ending Nov 30, 2018
FDA inspection 1073084 · Voluntary Action Indicated (VAI) · Wooster, OH
Key facts
| Inspection ID | 1073084 |
|---|---|
| Firm | Prentke Romich Company |
| FEI number | 3010819851 |
| Address | 1022 Heyl Rd |
| City | Wooster |
| State | OH |
| ZIP | 44691 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Nov 30, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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
- 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