Celmonze Sdn Bhd
⚠️ Moderate Risk
FEI: 3008776319 • Petaling Jaya, Selangor • MALAYSIA
FEI Number
3008776319
Location
Petaling Jaya, Selangor
Country
MALAYSIAAddress
27, 105 Jalan Ss 20/, Petaling Jaya, Selangor, Malaysia
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
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).
Refusal History
Frequently Asked Questions
What is Celmonze Sdn Bhd's FDA import refusal history?
Celmonze Sdn Bhd (FEI: 3008776319) has 2 FDA import refusal record(s) in our database, spanning from 2/11/2013 to 2/11/2013.
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. Celmonze Sdn Bhd's FEI number is 3008776319.
What types of violations has Celmonze Sdn Bhd received?
Celmonze Sdn Bhd 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 Celmonze Sdn Bhd come from?
All FDA import refusal data for Celmonze Sdn Bhd 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.