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DSM HEALTH WORLDWIDE

⚠️ Moderate Risk

FEI: 3023261152 • Perai Penang • MALAYSIA

FEI

FEI Number

3023261152

📍

Location

Perai Penang

🇲🇾

Country

MALAYSIA
🏢

Address

Kompleks Autow World 19, , Perai Penang, , Malaysia

Moderate Risk

FDA Import Risk Assessment

44.9
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
7/28/2022
Latest Refusal
7/28/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
16.3×20%
Frequency
50.0×10%
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

753×

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).

4732×

LABELING

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

Refusal History

DateProductViolationsDivision
7/28/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
Division of Southeast Imports (DSEI)
7/28/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
Division of Southeast Imports (DSEI)
7/28/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/28/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/28/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DSM HEALTH WORLDWIDE's FDA import refusal history?

DSM HEALTH WORLDWIDE (FEI: 3023261152) has 5 FDA import refusal record(s) in our database, spanning from 7/28/2022 to 7/28/2022.

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. DSM HEALTH WORLDWIDE's FEI number is 3023261152.

What types of violations has DSM HEALTH WORLDWIDE received?

DSM HEALTH WORLDWIDE 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 DSM HEALTH WORLDWIDE come from?

All FDA import refusal data for DSM HEALTH WORLDWIDE 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.