Fazer
⚠️ Moderate Risk
FEI: 3003524669 • Helsinki, Helsinki-Uusimaa • FINLAND
FEI Number
3003524669
Location
Helsinki, Helsinki-Uusimaa
Country
FINLANDAddress
Pl 110, , Helsinki, Helsinki-Uusimaa, Finland
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
NO ENGLISH
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)).
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.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2019 | 33UYY02CHEWING GUM (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 33AYY08LICORICE CANDY, HARD, WITH NUT OR NUT PRODUCTS (NOT COCONUT) (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 33AYY08LICORICE CANDY, HARD, WITH NUT OR NUT PRODUCTS (NOT COCONUT) (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 34YYY99CHOCOLATE AND COCOA PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 34KYY04CHOCOLATE BARS | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 34KYY04CHOCOLATE BARS | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 33EYY99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/6/2019 | 33EYY99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 6/8/2017 | 33EGT08LICORICE CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of Northern Border Imports (DNBI) | |
| 7/2/2013 | 33YFE99CANDY WITHOUT CHOCOLATE N.E.C. | Atlanta District Office (ATL-DO) | |
| 5/18/2007 | 33EGE08LICORICE CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Fazer's FDA import refusal history?
Fazer (FEI: 3003524669) has 11 FDA import refusal record(s) in our database, spanning from 5/18/2007 to 6/6/2019.
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. Fazer's FEI number is 3003524669.
What types of violations has Fazer received?
Fazer has been cited for 9 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 Fazer come from?
All FDA import refusal data for Fazer 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.