REXFIELD ENTERPRISE
⚠️ Moderate Risk
FEI: 3013286681 • Achimota, Greater Accra • GHANA
FEI Number
3013286681
Location
Achimota, Greater Accra
Country
GHANAAddress
New Achimota Kingsby Roundabout, No 65 Justice Brobbey Street, Achimota, 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
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).
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.
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.
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2018 | 16IFH58TILAPIA, HOT SMOKED, FISH | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 3/29/2018 | 16IFH58TILAPIA, HOT SMOKED, FISH | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 3/29/2018 | 16IFH37SNAPPER (RED, GRAY, MALABAR, ETC.), HOT SMOKED, FISH | 2580MFRHACCP | Division of Northeast Imports (DNEI) |
| 10/4/2017 | 63VBU99DEPIGMENTOR N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/3/2017 | 62UAY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Northeast Imports (DNEI) | |
| 10/3/2017 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/28/2017 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/28/2017 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is REXFIELD ENTERPRISE's FDA import refusal history?
REXFIELD ENTERPRISE (FEI: 3013286681) has 8 FDA import refusal record(s) in our database, spanning from 9/28/2017 to 3/29/2018.
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. REXFIELD ENTERPRISE's FEI number is 3013286681.
What types of violations has REXFIELD ENTERPRISE received?
REXFIELD ENTERPRISE has been cited for 10 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 REXFIELD ENTERPRISE come from?
All FDA import refusal data for REXFIELD 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.