Biopak Limited
⚠️ Moderate Risk
FEI: 3004204724 • Edmonton, ALBERTA • CANADA
FEI Number
3004204724
Location
Edmonton, ALBERTA
Country
CANADAAddress
7824 Avenue /#51, , Edmonton, 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
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).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
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.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/31/2005 | 54CCE99PROTEIN N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 12/22/2004 | 54FGF12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | Seattle District Office (SEA-DO) | |
| 4/11/2004 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 4/11/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 3/19/2004 | 60LDJ99ANALGESIC, N.E.C. | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 2/27/2004 | 60LDJ99ANALGESIC, N.E.C. | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Biopak Limited's FDA import refusal history?
Biopak Limited (FEI: 3004204724) has 6 FDA import refusal record(s) in our database, spanning from 2/27/2004 to 5/31/2005.
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. Biopak Limited's FEI number is 3004204724.
What types of violations has Biopak Limited received?
Biopak Limited has been cited for 6 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 Biopak Limited come from?
All FDA import refusal data for Biopak Limited 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.