Lever Ponds Ltd Product Devlpmnt
⚠️ Moderate Risk
FEI: 3003999035 • Umhlanga, Kwazulu-Natal • SOUTH AFRICA
FEI Number
3003999035
Location
Umhlanga, Kwazulu-Natal
Country
SOUTH AFRICAAddress
15 Nollsworth Crescent, , Umhlanga, Kwazulu-Natal, South Africa
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Lever Ponds Ltd Product Devlpmnt's FDA import refusal history?
Lever Ponds Ltd Product Devlpmnt (FEI: 3003999035) has 5 FDA import refusal record(s) in our database, spanning from 8/29/2003 to 8/29/2003.
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. Lever Ponds Ltd Product Devlpmnt's FEI number is 3003999035.
What types of violations has Lever Ponds Ltd Product Devlpmnt received?
Lever Ponds Ltd Product Devlpmnt has been cited for 4 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 Lever Ponds Ltd Product Devlpmnt come from?
All FDA import refusal data for Lever Ponds Ltd Product Devlpmnt 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.