Fir And Myrtle
⚠️ Moderate Risk
FEI: 3012240201 • Canmore, Alberta • CANADA
FEI Number
3012240201
Location
Canmore, Alberta
Country
CANADAAddress
1727 Mountain Ave, , Canmore, Alberta, 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
NCONTACT
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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2016 | 54AYQ99VITAMIN, N.E.C. | Seattle District Office (SEA-DO) | |
| 6/23/2016 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) | |
| 6/1/2016 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 6/1/2016 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Minneapolis District Office (MIN-DO) | |
| 6/1/2016 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Fir And Myrtle's FDA import refusal history?
Fir And Myrtle (FEI: 3012240201) has 5 FDA import refusal record(s) in our database, spanning from 6/1/2016 to 6/23/2016.
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. Fir And Myrtle's FEI number is 3012240201.
What types of violations has Fir And Myrtle received?
Fir And Myrtle 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 Fir And Myrtle come from?
All FDA import refusal data for Fir And Myrtle 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.