ETS BENJAMIN SHOPPING
⚠️ Moderate Risk
FEI: 3015212020 • Conakry • GUINEA
FEI Number
3015212020
Location
Conakry
Country
GUINEAAddress
B.P 45 Quatier Rue Dixinn, , Conakry, , Guinea
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
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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2020 | 54YEY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/16/2020 | 56BCH05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is ETS BENJAMIN SHOPPING's FDA import refusal history?
ETS BENJAMIN SHOPPING (FEI: 3015212020) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2020 to 12/16/2020.
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. ETS BENJAMIN SHOPPING's FEI number is 3015212020.
What types of violations has ETS BENJAMIN SHOPPING received?
ETS BENJAMIN SHOPPING has been cited for 4 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 ETS BENJAMIN SHOPPING come from?
All FDA import refusal data for ETS BENJAMIN SHOPPING 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.