Dan Danny Enterprise
⚠️ Moderate Risk
FEI: 3017803117 • Tapia, Greater Accra • GHANA
FEI Number
3017803117
Location
Tapia, Greater Accra
Country
GHANAAddress
196/T H-No., , Tapia, Greater Accra, Ghana
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 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)).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2023 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 25JGT16CASSAVA (ROOT AND TUBER VEGETABLE) | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 02HGT01TAPIOCA STARCH PRODUCT | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 22HGT99OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 03AGT03BISCUITS | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 24AGT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 4/11/2023 | 23BGT07PEANUT, SHELLED | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 11/30/2021 | 53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Dan Danny Enterprise's FDA import refusal history?
Dan Danny Enterprise (FEI: 3017803117) has 8 FDA import refusal record(s) in our database, spanning from 11/30/2021 to 4/11/2023.
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. Dan Danny Enterprise's FEI number is 3017803117.
What types of violations has Dan Danny Enterprise received?
Dan Danny Enterprise 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 Dan Danny Enterprise come from?
All FDA import refusal data for Dan Danny Enterprise 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.