Company
IndonesiaP.T. Sankei Medical Industries, Serang, Indonesia – FDA Inspections
Inspection records and compliance data for P.T. Sankei Medical Industries in Serang. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected May 11, 2023.
Company Profile
This profile covers P.T. Sankei Medical Industries based in Serang, Indonesia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected April 14, 2016. Last inspected May 11, 2023.
Most cited issue areas
- Design control - no procedures1 inspection
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 11, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1207456 |
| April 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 969061 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
P.T. Sankei Medical Industries
FEI Number
3001576493
Address
Jl. Mordern Inustri Iii, Komp. Bpsp A- 12, Serang, Indonesia
Country
Indonesia
ID: dc3fa15f-5914-4765-82ca-1c46477bcf51