PZ Cussons Industries (Ghana) Ltd.
⚠️ Moderate Risk
FEI: 3006024238 • Tema, Benue State • NIGERIA
FEI Number
3006024238
Location
Tema, Benue State
Country
NIGERIAAddress
P.O. Box 628, , Tema, Benue State, Nigeria
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).
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2014 | 66YBQ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 8/5/2008 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/18/2007 | 62MBQ08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/18/2007 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is PZ Cussons Industries (Ghana) Ltd.'s FDA import refusal history?
PZ Cussons Industries (Ghana) Ltd. (FEI: 3006024238) has 5 FDA import refusal record(s) in our database, spanning from 10/18/2007 to 6/6/2014.
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. PZ Cussons Industries (Ghana) Ltd.'s FEI number is 3006024238.
What types of violations has PZ Cussons Industries (Ghana) Ltd. received?
PZ Cussons Industries (Ghana) Ltd. has been cited for 6 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 PZ Cussons Industries (Ghana) Ltd. come from?
All FDA import refusal data for PZ Cussons Industries (Ghana) Ltd. 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.