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L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG

⚠️ Moderate Risk

FEI: 3002519438 • Karlsruhe, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3002519438

📍

Location

Karlsruhe, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Hertzstr. 175, , Karlsruhe, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

46.9
LowModerateHighCritical

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

Statistics

24
Total Refusals
2
Unique Violations
3/6/2020
Latest Refusal
1/22/2015
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
51.8×30%
Recency
0.0×20%
Frequency
46.8×10%
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

11814×

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).

7510×

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
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/6/2020
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
3/20/2019
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
1/22/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Florida District Office (FLA-DO)
1/22/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG's FDA import refusal history?

L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG (FEI: 3002519438) has 24 FDA import refusal record(s) in our database, spanning from 1/22/2015 to 3/6/2020.

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. L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG's FEI number is 3002519438.

What types of violations has L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG received?

L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG 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 L'OREAL PRODUKTION DEUTSCHLAND GmbH co KG come from?

All FDA import refusal data for L'OREAL PRODUKTION DEUTSCHLAND 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.