PZ Nigeria Limited
⚠️ Moderate Risk
FEI: 3006742009 • Lagos, Ng-La • NIGERIA
FEI Number
3006742009
Location
Lagos, Ng-La
Country
NIGERIAAddress
Ilupeju, 45/47 Town Planning Way, Lagos, Ng-La, 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
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.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2021 | 60FBY03TALC (ADSORBANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/30/2021 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/4/2020 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2017 | 62MBL08MENTHOL (ANTI-PRURITIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 11/13/2015 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | New York District Office (NYK-DO) | |
| 3/31/2015 | 60FBR03TALC (ADSORBANT) | Division of Northeast Imports (DNEI) | |
| 10/27/2014 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 6/6/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 2/20/2013 | 62MDO01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 10/29/2012 | 60FBZ03TALC (ADSORBANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/7/2011 | 62MBL08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 8/26/2008 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/5/2008 | 60LBJ07CAMPHORATED OIL | Los Angeles District Office (LOS-DO) | |
| 8/5/2008 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/29/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/29/2008 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/18/2007 | 62MBR08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/21/2005 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PZ Nigeria Limited's FDA import refusal history?
PZ Nigeria Limited (FEI: 3006742009) has 21 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 12/30/2021.
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 Nigeria Limited's FEI number is 3006742009.
What types of violations has PZ Nigeria Limited received?
PZ Nigeria Limited 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 PZ Nigeria Limited come from?
All FDA import refusal data for PZ Nigeria Limited 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.