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Chiara Ambra Cosmetics & Health Products Gmbh

⚠️ Moderate Risk

FEI: 3008740951 • Neuried, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3008740951

📍

Location

Neuried, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Am Grunloch 9, , Neuried, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/11/2012
Latest Refusal
5/11/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
5/11/2012
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
16DIRECTIONS
344WARNINGS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Chiara Ambra Cosmetics & Health Products Gmbh's FDA import refusal history?

Chiara Ambra Cosmetics & Health Products Gmbh (FEI: 3008740951) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2012 to 5/11/2012.

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. Chiara Ambra Cosmetics & Health Products Gmbh's FEI number is 3008740951.

What types of violations has Chiara Ambra Cosmetics & Health Products Gmbh received?

Chiara Ambra Cosmetics & Health Products 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 Chiara Ambra Cosmetics & Health Products Gmbh come from?

All FDA import refusal data for Chiara Ambra Cosmetics & Health Products 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.