FDA inspection
BioTek America LLC: FDA inspection ending Jan 19, 2023
FDA inspection 1196626 · No Action Indicated (NAI) · Mansfield, OH
Key facts
| Inspection ID | 1196626 |
|---|---|
| Firm | BioTek America LLC |
| FEI number | 3022988848 |
| Address | 1009 Park Ave W |
| City | Mansfield |
| State | OH |
| ZIP | 44906-2809 |
| Fiscal year | 2023 |
| Inspection end date | Jan 19, 2023 |
| 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