Coty Prestige Travel
⚠️ Moderate Risk
FEI: 3005827534 • Mainz, Rhineland-Palatinate • GERMANY
FEI Number
3005827534
Location
Mainz, Rhineland-Palatinate
Country
GERMANYAddress
Rheinstr. 4 E, , Mainz, Rhineland-Palatinate, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2007 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/27/2007 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 1/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 1/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 1/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 1/8/2007 | 65LBJ99PROTECTANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/28/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/11/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/11/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/11/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Coty Prestige Travel's FDA import refusal history?
Coty Prestige Travel (FEI: 3005827534) has 11 FDA import refusal record(s) in our database, spanning from 8/11/2006 to 12/13/2007.
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. Coty Prestige Travel's FEI number is 3005827534.
What types of violations has Coty Prestige Travel received?
Coty Prestige Travel has been cited for 2 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 Coty Prestige Travel come from?
All FDA import refusal data for Coty Prestige Travel 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.