NEOGENESIS HEALTH MANUFACTURING
⚠️ High Risk
FEI: 3027684173 • Strydompark • SOUTH AFRICA
FEI Number
3027684173
Location
Strydompark
Country
SOUTH AFRICAAddress
75 Tubgsten Road, , Strydompark, , South Africa
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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.
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 |
|---|---|---|---|
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY58SAW PALMETTO (HERBAL & BOTANICALS, NOT TEAS) | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/13/2023 | 54FEY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NEOGENESIS HEALTH MANUFACTURING's FDA import refusal history?
NEOGENESIS HEALTH MANUFACTURING (FEI: 3027684173) has 11 FDA import refusal record(s) in our database, spanning from 11/13/2023 to 11/13/2023.
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. NEOGENESIS HEALTH MANUFACTURING's FEI number is 3027684173.
What types of violations has NEOGENESIS HEALTH MANUFACTURING received?
NEOGENESIS HEALTH MANUFACTURING has been cited for 3 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 NEOGENESIS HEALTH MANUFACTURING come from?
All FDA import refusal data for NEOGENESIS HEALTH MANUFACTURING 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.