Vita Health Products Inc.
⚠️ High Risk
FEI: 3001804387 • Winnipeg, Manitoba • CANADA
FEI Number
3001804387
Location
Winnipeg, Manitoba
Country
CANADAAddress
150 Beghin Ave, , Winnipeg, Manitoba, 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).
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).
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.
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2024 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 61PCS99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2020 | 62GDY01ALCLOFENAC (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2012 | 62UDA08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/26/2010 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/2/2008 | 65QBB99RELAXANT N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/10/2008 | 60LPB05ASPIRIN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/29/2007 | 60LAA05ASPIRIN (ANALGESIC) | Seattle District Office (SEA-DO) | |
| 11/8/2006 | 60LBB05ASPIRIN (ANALGESIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 2/27/2006 | 60CBA10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/17/2005 | 60CBA10PSEUDOEPHEDRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 3/4/2005 | 61XAY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2004 | 54ACY99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 4/13/2004 | 60LCY05ASPIRIN (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 8/26/2003 | 61XQA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2003 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/8/2002 | 54ABA17BIOTIN (VITAMIN H, COENZYME R) | Minneapolis District Office (MIN-DO) | |
| 7/8/2002 | 60LPY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Vita Health Products Inc.'s FDA import refusal history?
Vita Health Products Inc. (FEI: 3001804387) has 18 FDA import refusal record(s) in our database, spanning from 7/8/2002 to 4/10/2024.
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. Vita Health Products Inc.'s FEI number is 3001804387.
What types of violations has Vita Health Products Inc. received?
Vita Health Products Inc. 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 Vita Health Products Inc. come from?
All FDA import refusal data for Vita Health Products 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.