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Hans Schwarzkopf & Henkel Gmbh & Co. KG

✅ Low Risk

FEI: 1000294260 • Hamburg, Hamburg • GERMANY

FEI

FEI Number

1000294260

📍

Location

Hamburg, Hamburg

🇩🇪

Country

GERMANY
🏢

Address

Hohenzollernring 127-129, , Hamburg, Hamburg, Germany

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
5/5/2011
Latest Refusal
5/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

1181×

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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/5/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hans Schwarzkopf & Henkel Gmbh & Co. KG's FDA import refusal history?

Hans Schwarzkopf & Henkel Gmbh & Co. KG (FEI: 1000294260) has 1 FDA import refusal record(s) in our database, spanning from 5/5/2011 to 5/5/2011.

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. Hans Schwarzkopf & Henkel Gmbh & Co. KG's FEI number is 1000294260.

What types of violations has Hans Schwarzkopf & Henkel Gmbh & Co. KG received?

Hans Schwarzkopf & Henkel Gmbh & Co. KG 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 Hans Schwarzkopf & Henkel Gmbh & Co. KG come from?

All FDA import refusal data for Hans Schwarzkopf & Henkel Gmbh & Co. KG 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.