Holotropic International
⚠️ Moderate Risk
FEI: 3005909550 • Capetown • SOUTH AFRICA
FEI Number
3005909550
Location
Capetown
Country
SOUTH AFRICAAddress
09 Mill Street, , Capetown, , 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
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 |
|---|---|---|---|
| 6/24/2008 | 54YCB01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2008 | 54FCB08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2008 | 54FCC49GUARANA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2008 | 54FCC84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Holotropic International's FDA import refusal history?
Holotropic International (FEI: 3005909550) has 4 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 6/24/2008.
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. Holotropic International's FEI number is 3005909550.
What types of violations has Holotropic International received?
Holotropic International has been cited for 1 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 Holotropic International come from?
All FDA import refusal data for Holotropic International 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.