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SUPERLIFE WORLD

⚠️ Moderate Risk

FEI: 3015544702 • Kuala Lumpur, Wilayah Persekutuan • MALAYSIA

FEI

FEI Number

3015544702

📍

Location

Kuala Lumpur, Wilayah Persekutuan

🇲🇾

Country

MALAYSIA
🏢

Address

1-01 Shoplot Amaya Maluri, , Kuala Lumpur, Wilayah Persekutuan, Malaysia

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
8
Unique Violations
7/6/2021
Latest Refusal
8/14/2020
Earliest Refusal

Score Breakdown

Violation Severity
53.1×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

754×

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).

22802×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

2562×

INCONSPICU

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

2182×

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.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

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.

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
7/6/2021
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
320LACKS FIRM
75UNAPPROVED
Division of Northern Border Imports (DNBI)
12/18/2020
54AYY99VITAMIN, N.E.C.
218LIST INGRE
2280DIRSEXMPT
256INCONSPICU
473LABELING
482NUTRIT LBL
75UNAPPROVED
Division of Northern Border Imports (DNBI)
12/18/2020
54AYY99VITAMIN, N.E.C.
218LIST INGRE
2280DIRSEXMPT
256INCONSPICU
274COLOR LBLG
473LABELING
482NUTRIT LBL
75UNAPPROVED
Division of Northern Border Imports (DNBI)
8/14/2020
54AYY99VITAMIN, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SUPERLIFE WORLD's FDA import refusal history?

SUPERLIFE WORLD (FEI: 3015544702) has 4 FDA import refusal record(s) in our database, spanning from 8/14/2020 to 7/6/2021.

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. SUPERLIFE WORLD's FEI number is 3015544702.

What types of violations has SUPERLIFE WORLD received?

SUPERLIFE WORLD has been cited for 8 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 SUPERLIFE WORLD come from?

All FDA import refusal data for SUPERLIFE WORLD 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.