Laboratoires ZANNINI
⚠️ Moderate Risk
FEI: 3011386729 • St Raphael, VAR • FRANCE
FEI Number
3011386729
Location
St Raphael, VAR
Country
FRANCEAddress
Technoparc Epsilon 1, 416 rue Isaac Newton, St Raphael, VAR, France
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2016 | 54FCA48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 1/8/2016 | 54FCA44ELEUTHEROCOCCUS (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 1/8/2016 | 54CCA09GLYCINE (PROTEIN) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54YCA01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54FCA87PASSIONFLOWER (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54FCA49GUARANA (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54FCA98BILBERRY (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54GCA04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54FCA12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | New Orleans District Office (NOL-DO) | |
| 11/30/2015 | 54FCA98BILBERRY (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/30/2015 | 54FCA88GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoires ZANNINI's FDA import refusal history?
Laboratoires ZANNINI (FEI: 3011386729) has 11 FDA import refusal record(s) in our database, spanning from 11/30/2015 to 1/8/2016.
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. Laboratoires ZANNINI's FEI number is 3011386729.
What types of violations has Laboratoires ZANNINI received?
Laboratoires ZANNINI 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 Laboratoires ZANNINI come from?
All FDA import refusal data for Laboratoires ZANNINI 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.