ImportRefusal LogoImportRefusal

Ace Health Products Sdn Bhd

✅ Low Risk

FEI: 3004670932 • Semenyih, Selangor • MALAYSIA

FEI

FEI Number

3004670932

📍

Location

Semenyih, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

1 Jalan P 2/16, , Semenyih, Selangor, Malaysia

Low Risk

FDA Import Risk Assessment

23.4
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
5
Unique Violations
3/9/2007
Latest Refusal
10/28/2002
Earliest Refusal

Score Breakdown

Violation Severity
44.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.6×10%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

31401×

SBGINSENG

The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
3/9/2007
54YCE04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS
2120UNSFDIETSP
2300DIETARYLBL
3140SBGINSENG
Seattle District Office (SEA-DO)
10/28/2002
31LYY99TEA, DECAFFEINATED, N.E.C.
218LIST INGRE
320LACKS FIRM
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ace Health Products Sdn Bhd's FDA import refusal history?

Ace Health Products Sdn Bhd (FEI: 3004670932) has 2 FDA import refusal record(s) in our database, spanning from 10/28/2002 to 3/9/2007.

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. Ace Health Products Sdn Bhd's FEI number is 3004670932.

What types of violations has Ace Health Products Sdn Bhd received?

Ace Health Products Sdn Bhd has been cited for 5 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 Ace Health Products Sdn Bhd come from?

All FDA import refusal data for Ace Health Products 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.