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BETELCARE SDN BHD

⚠️ Moderate Risk

FEI: 3366 • Kapar, Selangor • MALAYSIA

FEI

FEI Number

3366

📍

Location

Kapar, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 3342, 7 1/2 Mi Off Jalan Kapar, Jalan Keretapi Lama, Kapar, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

34.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
2
Unique Violations
11/9/2021
Latest Refusal
12/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
62.0×40%
Refusal Volume
28.8×30%
Recency
2.0×20%
Frequency
3.1×10%
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

4774×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

3411×

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

DateProductViolationsDivision
11/9/2021
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Division of West Coast Imports (DWCI)
4/8/2021
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Division of Southwest Imports (DSWI)
4/24/2009
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Florida District Office (FLA-DO)
3/30/2009
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Division of Southeast Imports (DSEI)
12/27/2005
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is BETELCARE SDN BHD's FDA import refusal history?

BETELCARE SDN BHD (FEI: 3366) has 5 FDA import refusal record(s) in our database, spanning from 12/27/2005 to 11/9/2021.

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. BETELCARE SDN BHD's FEI number is 3366.

What types of violations has BETELCARE SDN BHD received?

BETELCARE SDN BHD 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 BETELCARE SDN BHD come from?

All FDA import refusal data for BETELCARE 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.