Rama Yogaswara
⚠️ Moderate Risk
FEI: 3008740316 • Bandung, Jawa Barat • INDONESIA
FEI Number
3008740316
Location
Bandung, Jawa Barat
Country
INDONESIAAddress
37 Jln Embong, , Bandung, Jawa Barat, 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
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).
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.
Refusal History
Frequently Asked Questions
What is Rama Yogaswara's FDA import refusal history?
Rama Yogaswara (FEI: 3008740316) has 3 FDA import refusal record(s) in our database, spanning from 1/9/2012 to 1/29/2013.
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. Rama Yogaswara's FEI number is 3008740316.
What types of violations has Rama Yogaswara received?
Rama Yogaswara 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 Rama Yogaswara come from?
All FDA import refusal data for Rama Yogaswara 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.