Sanbe Farma
⚠️ High Risk
FEI: 3012197830 • Jabar • INDONESIA
FEI Number
3012197830
Location
Jabar
Country
INDONESIAAddress
Tamansari No 10-14 Bandon 6, , Jabar, , Indonesia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Sanbe Farma's FDA import refusal history?
Sanbe Farma (FEI: 3012197830) has 2 FDA import refusal record(s) in our database, spanning from 3/8/2022 to 5/28/2025.
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. Sanbe Farma's FEI number is 3012197830.
What types of violations has Sanbe Farma received?
Sanbe Farma has been cited for 1 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 Sanbe Farma come from?
All FDA import refusal data for Sanbe Farma 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.