Traditional Medicinals, Inc
⚠️ Moderate Risk
FEI: 2917201 • Sebastopol, CA • UNITED STATES
FEI Number
2917201
Location
Sebastopol, CA
Country
UNITED STATESAddress
4515 Ross Rd, , Sebastopol, CA, United States
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.
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2004 | 54YCW99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 12/14/2004 | 54ECT48GINKGO BILOBA (HERBAL & BOTANICAL TEAS) | New York District Office (NYK-DO) | |
| 12/14/2004 | 54YCW99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 12/14/2004 | 54ECT48GINKGO BILOBA (HERBAL & BOTANICAL TEAS) | New York District Office (NYK-DO) | |
| 11/22/2004 | 54YCW99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/19/2004 | 54ECT48GINKGO BILOBA (HERBAL & BOTANICAL TEAS) | 218LIST INGRE | New York District Office (NYK-DO) |
| 11/19/2004 | 31KAT99TEA, N.E.C. | 218LIST INGRE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Traditional Medicinals, Inc's FDA import refusal history?
Traditional Medicinals, Inc (FEI: 2917201) has 7 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 12/14/2004.
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. Traditional Medicinals, Inc's FEI number is 2917201.
What types of violations has Traditional Medicinals, Inc received?
Traditional Medicinals, Inc 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 Traditional Medicinals, Inc come from?
All FDA import refusal data for Traditional Medicinals, Inc 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.