Amoahimaah Ent
⚠️ High Risk
FEI: 3004865299 • Adum Kumasi - Accra • GHANA
FEI Number
3004865299
Location
Adum Kumasi - Accra
Country
GHANAAddress
Prempen Street, , Adum Kumasi - Accra, , Ghana
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2007 | 16IFT21HERRING, HOT SMOKED, FISH | 249FILTHY | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Amoahimaah Ent's FDA import refusal history?
Amoahimaah Ent (FEI: 3004865299) has 16 FDA import refusal record(s) in our database, spanning from 11/7/2007 to 11/7/2007.
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. Amoahimaah Ent's FEI number is 3004865299.
What types of violations has Amoahimaah Ent received?
Amoahimaah Ent 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 Amoahimaah Ent come from?
All FDA import refusal data for Amoahimaah Ent 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.