GlycaNova Norway A/S
⚠️ Moderate Risk
FEI: 2000034984 • Gamle Fredrikstad, NO-01 • NORWAY
FEI Number
2000034984
Location
Gamle Fredrikstad, NO-01
Country
NORWAYAddress
Oraveien 2, , Gamle Fredrikstad, NO-01, Norway
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2023 | 28CGT99NATURAL EXTRACT OR FLAVOR, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/25/2018 | 28NHD99RAW MATERIAL FOR EXTRACTS AND FLAVORS, N.E.C. | 218LIST INGRE | Division of Southeast Imports (DSEI) |
| 1/25/2018 | 28NHD99RAW MATERIAL FOR EXTRACTS AND FLAVORS, N.E.C. | 218LIST INGRE | Division of Southeast Imports (DSEI) |
| 3/30/2012 | 62IIL99ANTI-NEOPLASTIC N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GlycaNova Norway A/S's FDA import refusal history?
GlycaNova Norway A/S (FEI: 2000034984) has 4 FDA import refusal record(s) in our database, spanning from 3/30/2012 to 7/31/2023.
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. GlycaNova Norway A/S's FEI number is 2000034984.
What types of violations has GlycaNova Norway A/S received?
GlycaNova Norway A/S 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 GlycaNova Norway A/S come from?
All FDA import refusal data for GlycaNova Norway A/S 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.