Terra Botanica Products Ltd.
⚠️ Moderate Risk
FEI: 3002514110 • Nakusp, British Columbia • CANADA
FEI Number
3002514110
Location
Nakusp, British Columbia
Country
CANADAAddress
268 Saddle Mountain Road, , Nakusp, British Columbia, Canada
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
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
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).
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:
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).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/1/2004 | 54YEL04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | Seattle District Office (SEA-DO) | |
| 9/29/2004 | 54FCL12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 3140SBGINSENG | Seattle District Office (SEA-DO) |
| 9/20/2004 | 54FEK12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Seattle District Office (SEA-DO) | |
| 9/20/2004 | 54FEK12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Seattle District Office (SEA-DO) | |
| 3/12/2004 | 54FEK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/16/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 82RX LEGEND | New Orleans District Office (NOL-DO) |
| 6/19/2002 | 54FEK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Seattle District Office (SEA-DO) |
| 6/19/2002 | 54FEK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 251POISONOUS | Seattle District Office (SEA-DO) |
| 11/15/2001 | 54AYY99VITAMIN, N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Terra Botanica Products Ltd.'s FDA import refusal history?
Terra Botanica Products Ltd. (FEI: 3002514110) has 10 FDA import refusal record(s) in our database, spanning from 11/15/2001 to 2/28/2005.
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. Terra Botanica Products Ltd.'s FEI number is 3002514110.
What types of violations has Terra Botanica Products Ltd. received?
Terra Botanica Products Ltd. has been cited for 7 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 Terra Botanica Products Ltd. come from?
All FDA import refusal data for Terra Botanica Products Ltd. 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.