Dni Ltd
⚠️ Moderate Risk
FEI: 3009162595 • Rishon Le-Tsiyon • ISRAEL
FEI Number
3009162595
Location
Rishon Le-Tsiyon
Country
ISRAELAddress
Zionrishon Le Zion, 11, Moshe Levi, Rishon Le-Tsiyon, , Israel
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.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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)).
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2011 | 54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 12/21/2011 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 12/21/2011 | 54EBR99HERBALS & BOTANICAL TEAS, N.E.C. | 260FALSE | New York District Office (NYK-DO) |
| 12/21/2011 | 54EBR99HERBALS & BOTANICAL TEAS, N.E.C. | 260FALSE | New York District Office (NYK-DO) |
| 12/21/2011 | 34YFT99CHOCOLATE AND COCOA PRODUCTS, N.E.C. | 256INCONSPICU | New York District Office (NYK-DO) |
| 12/21/2011 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 12/21/2011 | 63RBJ03OLAFLUR (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dni Ltd's FDA import refusal history?
Dni Ltd (FEI: 3009162595) has 7 FDA import refusal record(s) in our database, spanning from 12/21/2011 to 12/21/2011.
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. Dni Ltd's FEI number is 3009162595.
What types of violations has Dni Ltd received?
Dni Ltd has been cited for 7 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 Dni Ltd come from?
All FDA import refusal data for Dni Ltd 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.