Alafia Bitters Herbal Institute and Clinic
⚠️ High Risk
FEI: 3011423633 • Madina • GHANA
FEI Number
3011423633
Location
Madina
Country
GHANAAddress
House # MD2/4 Zongo Junction, , Madina, , 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
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).
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).
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.
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.
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2024 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/27/2024 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/29/2022 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/29/2022 | 61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/6/2022 | 56YAL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/4/2021 | 66YCL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/13/2021 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 3/10/2021 | 54KYL08ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/1/2018 | 66VIN99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/8/2018 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 2/8/2018 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 10/31/2017 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/8/2017 | 63HBL99CATHARTIC N.E.C. | 223FALSE | Division of Northeast Imports (DNEI) |
| 8/27/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/13/2014 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 5/28/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/21/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 2/16/2010 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New England District Office (NWE-DO) | |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/6/2005 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Alafia Bitters Herbal Institute and Clinic's FDA import refusal history?
Alafia Bitters Herbal Institute and Clinic (FEI: 3011423633) has 20 FDA import refusal record(s) in our database, spanning from 9/6/2005 to 6/27/2024.
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. Alafia Bitters Herbal Institute and Clinic's FEI number is 3011423633.
What types of violations has Alafia Bitters Herbal Institute and Clinic received?
Alafia Bitters Herbal Institute and Clinic has been cited for 9 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 Alafia Bitters Herbal Institute and Clinic come from?
All FDA import refusal data for Alafia Bitters Herbal Institute and Clinic 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.