THE FERTIL - 24 SERVICES
⚠️ Moderate Risk
FEI: 3014008418 • Port Harcourt • NIGERIA
FEI Number
3014008418
Location
Port Harcourt
Country
NIGERIAAddress
1 Chief Street Oppositeopen Doors, Church Off Ada George Road, Port Harcourt, , 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
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.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/6/2017 | 54FCE56RED CLOVER (HERBAL & BOTANICALS, NOT TEAS) | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is THE FERTIL - 24 SERVICES's FDA import refusal history?
THE FERTIL - 24 SERVICES (FEI: 3014008418) has 5 FDA import refusal record(s) in our database, spanning from 12/6/2017 to 12/6/2017.
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. THE FERTIL - 24 SERVICES's FEI number is 3014008418.
What types of violations has THE FERTIL - 24 SERVICES received?
THE FERTIL - 24 SERVICES 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 THE FERTIL - 24 SERVICES come from?
All FDA import refusal data for THE FERTIL - 24 SERVICES 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.