Evans Medical PLC
⚠️ Moderate Risk
FEI: 3002493597 • Agbara, Ogun State • NIGERIA
FEI Number
3002493597
Location
Agbara, Ogun State
Country
NIGERIAAddress
Km 32, Lagos-Badagry Expressway, Agbara, Ogun 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
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(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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2024 | 61XBY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 61XBY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 12/27/2011 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 8/5/2008 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/18/2007 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/5/2006 | 61XDK08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/5/2004 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/13/2004 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Evans Medical PLC's FDA import refusal history?
Evans Medical PLC (FEI: 3002493597) has 9 FDA import refusal record(s) in our database, spanning from 4/13/2004 to 7/15/2024.
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. Evans Medical PLC's FEI number is 3002493597.
What types of violations has Evans Medical PLC received?
Evans Medical PLC has been cited for 5 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 Evans Medical PLC come from?
All FDA import refusal data for Evans Medical PLC 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.