VSF SDN BHD
⚠️ Moderate Risk
FEI: 3004336201 • Shah Alam, Selangor • MALAYSIA
FEI Number
3004336201
Location
Shah Alam, Selangor
Country
MALAYSIAAddress
4g Jalan Suria Ru5/R, , Shah Alam, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEEDS ACID
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2016 | 61HBL99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/3/2011 | 31AGT03COFFEE, INSTANT | 218LIST INGRE | New York District Office (NYK-DO) |
| 12/23/2010 | 29AGT01SOFT DRINK, BERRY FRUIT FLAVORED, NONCARBONATED | New York District Office (NYK-DO) | |
| 6/26/2007 | 16YFT12SHRIMP PASTE, FISHERY PRODUCTS, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 3/23/2006 | 29YFF99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | New York District Office (NYK-DO) | |
| 7/5/2005 | 28FGT04CURRY POWDER, GROUND, CRACKED, WITHOUT SALT | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 5/19/2005 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 1/21/2005 | 29CEF99NONALCOHOLIC BEVERAGES, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 9/10/2004 | 07YCF99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 9/10/2004 | 21VFP99SUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C. | 48NEEDS ACID | New York District Office (NYK-DO) |
| 1/15/2003 | 29YFF99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 62NEEDS FCE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is VSF SDN BHD's FDA import refusal history?
VSF SDN BHD (FEI: 3004336201) has 11 FDA import refusal record(s) in our database, spanning from 1/15/2003 to 6/16/2016.
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. VSF SDN BHD's FEI number is 3004336201.
What types of violations has VSF SDN BHD received?
VSF SDN BHD has been cited for 16 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 VSF SDN BHD come from?
All FDA import refusal data for VSF 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.