Cv Prasada Bali Utama
✅ Low Risk
FEI: 3006334592 • Bali • INDONESIA
FEI Number
3006334592
Location
Bali
Country
INDONESIAAddress
Qq. Pt Rim Express Indonesia, , Bali, , Indonesia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Cv Prasada Bali Utama's FDA import refusal history?
Cv Prasada Bali Utama (FEI: 3006334592) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2007 to 7/24/2007.
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 Prasada Bali Utama's FEI number is 3006334592.
What types of violations has Cv Prasada Bali Utama received?
Cv Prasada Bali Utama 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 Prasada Bali Utama come from?
All FDA import refusal data for Cv Prasada Bali Utama 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.