FDA inspection
BioTek America, LLC: FDA inspection ending Jul 31, 2024
FDA inspection 1250232 · No Action Indicated (NAI) · Newark, OH
Key facts
| Inspection ID | 1250232 |
|---|---|
| Firm | BioTek America, LLC |
| FEI number | 3029965162 |
| Address | 1068 Mount Vernon Rd |
| City | Newark |
| State | OH |
| ZIP | 43055-3031 |
| Fiscal year | 2024 |
| Inspection end date | Jul 31, 2024 |
| Classification | No Action Indicated (NAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- None Citations
- None 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