Bioharmony
⚠️ Moderate Risk
FEI: 3004040606 • Cape Town, Western Cape • SOUTH AFRICA
FEI Number
3004040606
Location
Cape Town, Western Cape
Country
SOUTH AFRICAAddress
14 Piers Road, , Cape Town, 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
UNSFDIETSP
The article appears to be a dietary supplement or 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.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2006 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/24/2005 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 8/24/2005 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bioharmony's FDA import refusal history?
Bioharmony (FEI: 3004040606) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2005 to 5/9/2006.
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. Bioharmony's FEI number is 3004040606.
What types of violations has Bioharmony received?
Bioharmony has been cited for 2 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 Bioharmony come from?
All FDA import refusal data for Bioharmony 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.