Beaute Pacifique Aps
⚠️ High Risk
FEI: 3010185816 • Hadsund • DENMARK
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/2/2013 | 53LI06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/2/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Beaute Pacifique Aps's FDA import refusal history?
Beaute Pacifique Aps (FEI: 3010185816) has 20 FDA import refusal record(s) in our database, spanning from 7/2/2013 to 7/2/2013.
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. Beaute Pacifique Aps's FEI number is 3010185816.
What types of violations has Beaute Pacifique Aps received?
Beaute Pacifique Aps has been cited for 3 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 Beaute Pacifique Aps come from?
All FDA import refusal data for Beaute Pacifique Aps 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.