DSM Nutritional Products Canada
⚠️ Moderate Risk
FEI: 3003891258 • Dartmouth, Nova Scotia • CANADA
FEI Number
3003891258
Location
Dartmouth, Nova Scotia
Country
CANADAAddress
105 Neptune Cres, , Dartmouth, Nova Scotia, 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
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.
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2005 | 54HAR05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 9/14/2005 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2005 | 54YBE03CHLORELLA (TABLET), VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | New Orleans District Office (NOL-DO) | |
| 8/15/2002 | 63HAH99CATHARTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/25/2002 | 54GBE04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 4/5/2002 | 54HBY04FISH OIL (FATS AND LIPID SUBSTANCES) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 11/9/2001 | 54HYY04FISH OIL (FATS AND LIPID SUBSTANCES) | Cincinnati District Office (CIN-DO) | |
| 10/28/2001 | 54HYY04FISH OIL (FATS AND LIPID SUBSTANCES) | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is DSM Nutritional Products Canada's FDA import refusal history?
DSM Nutritional Products Canada (FEI: 3003891258) has 8 FDA import refusal record(s) in our database, spanning from 10/28/2001 to 10/27/2005.
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. DSM Nutritional Products Canada's FEI number is 3003891258.
What types of violations has DSM Nutritional Products Canada received?
DSM Nutritional Products Canada 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 DSM Nutritional Products Canada come from?
All FDA import refusal data for DSM Nutritional Products Canada 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.