FDA inspection
P.T. Sankei Medical Industries: FDA inspection ending Apr 14, 2016
FDA inspection 969061 · Voluntary Action Indicated (VAI) · Serang
Key facts
| Inspection ID | 969061 |
|---|---|
| Firm | P.T. Sankei Medical Industries |
| FEI number | 3001576493 |
| Address | JL. Mordern Ind. III Komp. BPSP, A-12, Kawasan Industri Modern |
| City | Serang |
| Country | Indonesia |
| Fiscal year | 2016 |
| Inspection end date | Apr 14, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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