Swiss Caps Romania Srl
⚠️ Moderate Risk
FEI: 3012337953 • Cornu • ROMANIA
FEI Number
3012337953
Location
Cornu
Country
ROMANIAAddress
Carol Street 1 Ro-107 180, , Cornu, , Romania
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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)).
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.
DIETARYING
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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2016 | 54GCH01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | Division of Southeast Imports (DSEI) | |
| 9/29/2016 | 54GCH01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | Division of Southeast Imports (DSEI) | |
| 9/29/2016 | 54GCH01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | Division of Southeast Imports (DSEI) | |
| 9/29/2016 | 54GCH01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | Division of Southeast Imports (DSEI) | |
| 9/29/2016 | 54GCH01BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Swiss Caps Romania Srl's FDA import refusal history?
Swiss Caps Romania Srl (FEI: 3012337953) has 5 FDA import refusal record(s) in our database, spanning from 9/29/2016 to 9/29/2016.
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. Swiss Caps Romania Srl's FEI number is 3012337953.
What types of violations has Swiss Caps Romania Srl received?
Swiss Caps Romania Srl has been cited for 5 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 Swiss Caps Romania Srl come from?
All FDA import refusal data for Swiss Caps Romania Srl 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.