FDA inspection
P.T. Sankei Medical Industries: FDA inspection ending May 11, 2023
FDA inspection 1207456 · Official Action Indicated (OAI) · Serang
Key facts
| Inspection ID | 1207456 |
|---|---|
| Firm | P.T. Sankei Medical Industries |
| FEI number | 3001576493 |
| Address | Jl. Mordern Inustri Iii, Komp. Bpsp A- 12 |
| City | Serang |
| Country | Indonesia |
| Fiscal year | 2023 |
| Inspection end date | May 11, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 665754 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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