Elida Pond'S (Pty) Ltd
⚠️ Moderate Risk
FEI: 3003329598 • Durban, Kwazulu-Natal • SOUTH AFRICA
FEI Number
3003329598
Location
Durban, Kwazulu-Natal
Country
SOUTH AFRICAAddress
67 Maydon Road, , Durban, 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
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.
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.
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).
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 |
|---|---|---|---|
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/18/2003 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/29/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) | |
| 8/8/2003 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 473LABELING | Florida District Office (FLA-DO) |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Florida District Office (FLA-DO) | |
| 8/8/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 16DIRECTIONS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Elida Pond'S (Pty) Ltd's FDA import refusal history?
Elida Pond'S (Pty) Ltd (FEI: 3003329598) has 10 FDA import refusal record(s) in our database, spanning from 8/8/2003 to 11/18/2003.
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. Elida Pond'S (Pty) Ltd's FEI number is 3003329598.
What types of violations has Elida Pond'S (Pty) Ltd received?
Elida Pond'S (Pty) Ltd 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 Elida Pond'S (Pty) Ltd come from?
All FDA import refusal data for Elida Pond'S (Pty) 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.