Ars Vivendi
⚠️ Moderate Risk
FEI: 3002984482 • Weyerbusch • GERMANY
FEI Number
3002984482
Location
Weyerbusch
Country
GERMANYAddress
Herchener Str 10, , Weyerbusch, , Germany
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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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)).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 7/1/2003 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New Orleans District Office (NOL-DO) | |
| 7/1/2003 | 53CK07EYELASH AND EYEBROW DYE (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 7/1/2003 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 7/1/2003 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 7/1/2003 | 53GH07ROUGES (MAKEUP PREPARATIONS, NOT FOR EYES) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 7/1/2003 | 53MD02INDOOR TANNING PREPARATIONS (SUNTAN PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53KC05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53AC01BABY SHAMPOO (BABY PRODUCTS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53AY01BABY SHAMPOO (BABY PRODUCTS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/30/2003 | 63SAY99DENTAL PROTECTANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/26/2001 | 53SY11SHAVING PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53SY09ORAL HYGIENE PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53SY05HAIR PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53SY03EYE MAKE UP PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53SY07MAKEUP PREPARATIONS (NOT FOR THE EYES), COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 11/26/2001 | 53SY07MAKEUP PREPARATIONS (NOT FOR THE EYES), COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE) | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ars Vivendi's FDA import refusal history?
Ars Vivendi (FEI: 3002984482) has 22 FDA import refusal record(s) in our database, spanning from 11/26/2001 to 7/1/2003.
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. Ars Vivendi's FEI number is 3002984482.
What types of violations has Ars Vivendi received?
Ars Vivendi has been cited for 8 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 Ars Vivendi come from?
All FDA import refusal data for Ars Vivendi 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.