CV. ARUNA MANDALA
⚠️ Moderate Risk
FEI: 3012939513 • BADUNGDI • INDONESIA
FEI Number
3012939513
Location
BADUNGDI
Country
INDONESIAAddress
BTN.SEMBARA ASRI A- 12A, , BADUNGDI, , 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
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.
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. ARUNA MANDALA's FDA import refusal history?
CV. ARUNA MANDALA (FEI: 3012939513) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2019 to 10/28/2019.
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. ARUNA MANDALA's FEI number is 3012939513.
What types of violations has CV. ARUNA MANDALA received?
CV. ARUNA MANDALA 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. ARUNA MANDALA come from?
All FDA import refusal data for CV. ARUNA MANDALA 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.