Flora Manufacturing and Distributing Ltd.
⚠️ Moderate Risk
FEI: 3004284019 • Burnaby, British Columbia • CANADA
FEI Number
3004284019
Location
Burnaby, British Columbia
Country
CANADAAddress
7400 Fraser Park Dr, , Burnaby, 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
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).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/3/2022 | 54FCK50HAWTHORN (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/12/2015 | 31PCT99TEA SUBSTITUTES, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/22/2011 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/21/2009 | 54BCH08MAGNESIUM (MINERAL) | New Orleans District Office (NOL-DO) | |
| 10/5/2006 | 54YEY04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | Seattle District Office (SEA-DO) | |
| 2/17/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 2/14/2005 | 62UAL99ANTI-TUSSIVE/COLD N.E.C. | 335LACKS N/C | New Orleans District Office (NOL-DO) |
| 10/8/2004 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/10/2004 | 31KFT99TEA, N.E.C. | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 6/10/2004 | 31KFT99TEA, N.E.C. | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 6/10/2004 | 31KFT99TEA, N.E.C. | 238UNSAFE ADD | Seattle District Office (SEA-DO) |
| 10/17/2003 | 54ABA99VITAMIN, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 54ACA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New Orleans District Office (NOL-DO) |
| 1/14/2002 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 223FALSE | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Flora Manufacturing and Distributing Ltd.'s FDA import refusal history?
Flora Manufacturing and Distributing Ltd. (FEI: 3004284019) has 14 FDA import refusal record(s) in our database, spanning from 1/14/2002 to 2/3/2022.
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. Flora Manufacturing and Distributing Ltd.'s FEI number is 3004284019.
What types of violations has Flora Manufacturing and Distributing Ltd. received?
Flora Manufacturing and Distributing Ltd. has been cited for 9 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 Flora Manufacturing and Distributing Ltd. come from?
All FDA import refusal data for Flora Manufacturing and Distributing 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.