FDA inspection
Greiner Bio-One North America, Inc.: FDA inspection ending Dec 13, 2019
FDA inspection 1114241 · Official Action Indicated (OAI) · Monroe, NC
Key facts
| Inspection ID | 1114241 |
|---|---|
| Firm | Greiner Bio-One North America, Inc. |
| FEI number | 3001451379 |
| Address | 4238 Capital Dr |
| City | Monroe |
| State | NC |
| ZIP | 28110 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Dec 13, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 606266 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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