Bionutricia Manufacturing SDN BHD
⚠️ Moderate Risk
FEI: 3013821889 • Sungai Buloh, Selangor • MALAYSIA
FEI Number
3013821889
Location
Sungai Buloh, Selangor
Country
MALAYSIAAddress
No. 37, 39, 41 Jalan Tsb 1, Taman Perindustrian Sungai Buloh, Sungai Buloh, 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
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
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.
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2024 | 21WYY14TAMARIND, TOPPING OR SYRUP | 249FILTHY | Division of Southeast Imports (DSEI) |
| 7/30/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 45LY99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bionutricia Manufacturing SDN BHD's FDA import refusal history?
Bionutricia Manufacturing SDN BHD (FEI: 3013821889) has 4 FDA import refusal record(s) in our database, spanning from 5/6/2021 to 12/9/2024.
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. Bionutricia Manufacturing SDN BHD's FEI number is 3013821889.
What types of violations has Bionutricia Manufacturing SDN BHD received?
Bionutricia Manufacturing 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 Bionutricia Manufacturing SDN BHD come from?
All FDA import refusal data for Bionutricia Manufacturing 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.