Botanikur Inc.
⚠️ High Risk
FEI: 3014273103 • Saint-Roch-De-L'Achigan, Quebec • CANADA
FEI Number
3014273103
Location
Saint-Roch-De-L'Achigan, Quebec
Country
CANADAAddress
257 Armand-Majeau St S Local 3, , Saint-Roch-De-L'Achigan, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
PB-FOOD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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 |
|---|---|---|---|
| 5/22/2025 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/22/2025 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 6/11/2024 | 54FCL08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/21/2023 | 54FCL02ALFALFA (HERBAL & BOTANICALS, NOT TEAS) | 83NO PROCESS | Division of Northern Border Imports (DNBI) |
| 10/26/2023 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/26/2023 | 54KCR08ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 249FILTHY | Division of Northern Border Imports (DNBI) |
| 5/11/2023 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 308MFR INSAN | Division of Northern Border Imports (DNBI) |
| 12/9/2022 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 308MFR INSAN | Division of Northern Border Imports (DNBI) |
| 11/15/2021 | 54ICR02PSYLLIUM (FIBER) | Division of Northern Border Imports (DNBI) | |
| 10/5/2020 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/5/2020 | 54FCL07COMFREY (HERBAL & BOTANICALS, NOT TEAS) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Botanikur Inc.'s FDA import refusal history?
Botanikur Inc. (FEI: 3014273103) has 11 FDA import refusal record(s) in our database, spanning from 10/5/2020 to 5/22/2025.
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. Botanikur Inc.'s FEI number is 3014273103.
What types of violations has Botanikur Inc. received?
Botanikur Inc. 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 Botanikur Inc. come from?
All FDA import refusal data for Botanikur 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.