Fanda Hygiene Sdg Bhd
⚠️ Moderate Risk
FEI: 3007139428 • Kuala Lumpor • MALAYSIA
FEI Number
3007139428
Location
Kuala Lumpor
Country
MALAYSIAAddress
98 Jalan Metro Perdan Barat 13, , Kuala Lumpor, , 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is Fanda Hygiene Sdg Bhd's FDA import refusal history?
Fanda Hygiene Sdg Bhd (FEI: 3007139428) has 3 FDA import refusal record(s) in our database, spanning from 6/6/2011 to 6/6/2011.
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. Fanda Hygiene Sdg Bhd's FEI number is 3007139428.
What types of violations has Fanda Hygiene Sdg Bhd received?
Fanda Hygiene Sdg Bhd has been cited for 3 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 Fanda Hygiene Sdg Bhd come from?
All FDA import refusal data for Fanda Hygiene Sdg 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.