P.T. Sankei Medical Industries
⚠️ Moderate Risk
FEI: 3001576493 • Serang, Banten • INDONESIA
FEI Number
3001576493
Location
Serang, Banten
Country
INDONESIAAddress
Jl. Mordern Inustri Iii, Komp. Bpsp A- 12, , Serang, Banten, Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
3904
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of West Coast Imports (DWCI) | |
| 4/1/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of West Coast Imports (DWCI) | |
| 4/1/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of West Coast Imports (DWCI) | |
| 4/1/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of West Coast Imports (DWCI) | |
| 4/1/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is P.T. Sankei Medical Industries's FDA import refusal history?
P.T. Sankei Medical Industries (FEI: 3001576493) has 5 FDA import refusal record(s) in our database, spanning from 4/1/2024 to 4/1/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. P.T. Sankei Medical Industries's FEI number is 3001576493.
What types of violations has P.T. Sankei Medical Industries received?
P.T. Sankei Medical Industries has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about P.T. Sankei Medical Industries come from?
All FDA import refusal data for P.T. Sankei Medical Industries is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.