Produits De Beaute' Produktions Gmbh
⚠️ Moderate Risk
FEI: 3008989108 • Baden • 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
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 |
|---|---|---|---|
| 11/13/2012 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Produits De Beaute' Produktions Gmbh's FDA import refusal history?
Produits De Beaute' Produktions Gmbh (FEI: 3008989108) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 11/13/2012.
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. Produits De Beaute' Produktions Gmbh's FEI number is 3008989108.
What types of violations has Produits De Beaute' Produktions Gmbh received?
Produits De Beaute' Produktions Gmbh has been cited for 1 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 Produits De Beaute' Produktions Gmbh come from?
All FDA import refusal data for Produits De Beaute' Produktions Gmbh 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.