Afrigetics CC
⚠️ Moderate Risk
FEI: 3007554785 • Wilderness, Western Cape • SOUTH AFRICA
FEI Number
3007554785
Location
Wilderness, Western Cape
Country
SOUTH AFRICAAddress
381 Waterside Road, 6560, 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
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/20/2021 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Division of Northeast Imports (DNEI) |
| 9/19/2017 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 241PESTICIDE | Division of Northeast Imports (DNEI) |
| 6/14/2017 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 241PESTICIDE | Division of Northeast Imports (DNEI) |
| 8/19/2016 | 63HSC01BISACODYL (CATHARTIC) | Division of Northeast Imports (DNEI) | |
| 2/29/2016 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 4/26/2011 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | New York District Office (NYK-DO) |
| 9/2/2010 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Afrigetics CC's FDA import refusal history?
Afrigetics CC (FEI: 3007554785) has 7 FDA import refusal record(s) in our database, spanning from 9/2/2010 to 1/20/2021.
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. Afrigetics CC's FEI number is 3007554785.
What types of violations has Afrigetics CC received?
Afrigetics CC has been cited for 8 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 Afrigetics CC come from?
All FDA import refusal data for Afrigetics CC 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.