FDA inspection
Richter Helm Biologics GmbH and Co KG: FDA inspection ending Aug 28, 2019
FDA inspection 1123653 · Voluntary Action Indicated (VAI) · Bovenau
Key facts
| Inspection ID | 1123653 |
|---|---|
| Firm | Richter Helm Biologics GmbH and Co KG |
| FEI number | 3009883634 |
| Address | Dengelsberg 999 |
| City | Bovenau |
| Country | Germany |
| Fiscal year | 2019 |
| Inspection end date | Aug 28, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None 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