Edmark Industries Sendirian Berhad
⚠️ Moderate Risk
FEI: 2000030014 • Puchong, Selangor • MALAYSIA
FEI Number
2000030014
Location
Puchong, Selangor
Country
MALAYSIAAddress
Taman Perindustrian Kinrara, Section 2, No. 7 Jalan Tpk 2/3, Puchong, Selangor, 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
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
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.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
NO ENGLISH
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)).
HEALTH C
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 bears an unauthorized nutrient content/health claim.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2015 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 1/21/2015 | 09CYT05MILK, FLAVORED (CHOCOLATE, ETC.) | Division of Southeast Imports (DSEI) | |
| 1/21/2015 | 31AYY03COFFEE, INSTANT | Division of Southeast Imports (DSEI) | |
| 1/21/2015 | 31AYY03COFFEE, INSTANT | Division of Southeast Imports (DSEI) | |
| 1/21/2015 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Edmark Industries Sendirian Berhad's FDA import refusal history?
Edmark Industries Sendirian Berhad (FEI: 2000030014) has 5 FDA import refusal record(s) in our database, spanning from 1/21/2015 to 1/21/2015.
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. Edmark Industries Sendirian Berhad's FEI number is 2000030014.
What types of violations has Edmark Industries Sendirian Berhad received?
Edmark Industries Sendirian Berhad has been cited for 6 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 Edmark Industries Sendirian Berhad come from?
All FDA import refusal data for Edmark Industries Sendirian Berhad 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.