ImportRefusal LogoImportRefusal

Laboratoire Prodene Klintescape Leader

⚠️ Moderate Risk

FEI: 3006043562 • Alby Sur Cheran • FRANCE

FEI

FEI Number

3006043562

📍

Location

Alby Sur Cheran

🇫🇷

Country

FRANCE
🏢

Address

Champs De La Pierre, , Alby Sur Cheran, , France

Moderate Risk

FDA Import Risk Assessment

47.1
LowModerateHighCritical

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

Statistics

29
Total Refusals
3
Unique Violations
3/2/2009
Latest Refusal
2/25/2009
Earliest Refusal

Score Breakdown

Violation Severity
51.6×40%
Refusal Volume
54.7×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11829×

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

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
3/2/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
223FALSE
75UNAPPROVED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)
2/25/2009
61HAY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Laboratoire Prodene Klintescape Leader's FDA import refusal history?

Laboratoire Prodene Klintescape Leader (FEI: 3006043562) has 29 FDA import refusal record(s) in our database, spanning from 2/25/2009 to 3/2/2009.

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. Laboratoire Prodene Klintescape Leader's FEI number is 3006043562.

What types of violations has Laboratoire Prodene Klintescape Leader received?

Laboratoire Prodene Klintescape Leader 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 Laboratoire Prodene Klintescape Leader come from?

All FDA import refusal data for Laboratoire Prodene Klintescape Leader 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.