Cv.Artha Wi Jaya
⚠️ Moderate Risk
FEI: 3011010516 • Bekasi, Jabotabek • INDONESIA
FEI Number
3011010516
Location
Bekasi, Jabotabek
Country
INDONESIAAddress
Jln Sedap Malam 5, , Bekasi, Jabotabek, 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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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 Cv.Artha Wi Jaya's FDA import refusal history?
Cv.Artha Wi Jaya (FEI: 3011010516) has 1 FDA import refusal record(s) in our database, spanning from 10/20/2014 to 10/20/2014.
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. Cv.Artha Wi Jaya's FEI number is 3011010516.
What types of violations has Cv.Artha Wi Jaya received?
Cv.Artha Wi Jaya has been cited for 2 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 Cv.Artha Wi Jaya come from?
All FDA import refusal data for Cv.Artha Wi Jaya 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.