Peace Indo-Ghana
⚠️ Moderate Risk
FEI: 3011415064 • Unknown, Unknown • GHANA
FEI Number
3011415064
Location
Unknown, Unknown
Country
GHANAAddress
Unknown Street, , Unknown, Unknown, 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
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.
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).
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.
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2017 | 64ABY19TRICLOCARBAN (DISINFECTANT) | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 64ABY20TRICLOSAN (DISINFECTANT) | 333LACKS FIRM | Division of Northeast Imports (DNEI) |
| 3/31/2015 | 64ABU19TRICLOCARBAN (DISINFECTANT) | Division of Northeast Imports (DNEI) | |
| 3/31/2015 | 64ABU19TRICLOCARBAN (DISINFECTANT) | Division of Northeast Imports (DNEI) | |
| 3/31/2015 | 64ABU19TRICLOCARBAN (DISINFECTANT) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Peace Indo-Ghana's FDA import refusal history?
Peace Indo-Ghana (FEI: 3011415064) has 5 FDA import refusal record(s) in our database, spanning from 3/31/2015 to 10/31/2017.
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. Peace Indo-Ghana's FEI number is 3011415064.
What types of violations has Peace Indo-Ghana received?
Peace Indo-Ghana 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 Peace Indo-Ghana come from?
All FDA import refusal data for Peace Indo-Ghana 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.