Neptune Technologies
⚠️ Moderate Risk
FEI: 3003898904 • Sherbrooke, QC • CANADA
FEI Number
3003898904
Location
Sherbrooke, QC
Country
CANADAAddress
795 Rue Pepin, , Sherbrooke, QC, 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).
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.
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 |
|---|---|---|---|
| 4/18/2012 | 54HYK04FISH OIL (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/18/2012 | 54HYK04FISH OIL (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/18/2011 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/10/2011 | 54HBH05OMEGA-3 (FATS AND LIPID SUBSTANCES) | New England District Office (NWE-DO) | |
| 1/7/2004 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Neptune Technologies's FDA import refusal history?
Neptune Technologies (FEI: 3003898904) has 5 FDA import refusal record(s) in our database, spanning from 1/7/2004 to 4/18/2012.
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. Neptune Technologies's FEI number is 3003898904.
What types of violations has Neptune Technologies received?
Neptune Technologies 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 Neptune Technologies come from?
All FDA import refusal data for Neptune Technologies 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.