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Juvena Produits Of Beaute Gmbh

⚠️ Moderate Risk

FEI: 1000501683 • Baden-Baden, Baden-Wurttemberg • GERMANY

FEI

FEI Number

1000501683

📍

Location

Baden-Baden, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Blutenfeldplatz 8, , Baden-Baden, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

31.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
2/27/2015
Latest Refusal
8/31/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
8.6×10%
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

1183×

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).

751×

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

DateProductViolationsDivision
2/27/2015
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/31/2011
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
Cincinnati District Office (CIN-DO)
8/31/2011
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Juvena Produits Of Beaute Gmbh's FDA import refusal history?

Juvena Produits Of Beaute Gmbh (FEI: 1000501683) has 3 FDA import refusal record(s) in our database, spanning from 8/31/2011 to 2/27/2015.

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. Juvena Produits Of Beaute Gmbh's FEI number is 1000501683.

What types of violations has Juvena Produits Of Beaute Gmbh received?

Juvena Produits Of Beaute Gmbh 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 Juvena Produits Of Beaute Gmbh come from?

All FDA import refusal data for Juvena Produits Of Beaute 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.