FDA inspection
Purac Biochem BV: FDA inspection ending May 25, 2018
FDA inspection 1055916 · Voluntary Action Indicated (VAI) · Gorinchem
Key facts
| Inspection ID | 1055916 |
|---|---|
| Firm | Purac Biochem BV |
| FEI number | 3002806633 |
| Address | Arkelse Onderweg 46, P.O. Box 21 |
| City | Gorinchem |
| Country | Netherlands |
| Fiscal year | 2018 |
| Inspection end date | May 25, 2018 |
| 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