SCELETIUM SOURCE AFRICA
⚠️ Moderate Risk
FEI: 3015330947 • Wilderness, Western Cape • SOUTH AFRICA
FEI Number
3015330947
Location
Wilderness, Western Cape
Country
SOUTH AFRICAAddress
Farm 8/192 Bolangveli R, , Wilderness, Western Cape, 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
DIETARYLBL
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(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NDIDIETSP
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2024 | 54EBY99HERBALS & BOTANICAL TEAS, N.E.C. | 2300DIETARYLBL | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2300DIETARYLBL | Division of Southeast Imports (DSEI) |
| 3/18/2024 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 5/3/2021 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SCELETIUM SOURCE AFRICA's FDA import refusal history?
SCELETIUM SOURCE AFRICA (FEI: 3015330947) has 4 FDA import refusal record(s) in our database, spanning from 5/3/2021 to 3/19/2024.
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. SCELETIUM SOURCE AFRICA's FEI number is 3015330947.
What types of violations has SCELETIUM SOURCE AFRICA received?
SCELETIUM SOURCE AFRICA 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 SCELETIUM SOURCE AFRICA come from?
All FDA import refusal data for SCELETIUM SOURCE AFRICA 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.