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Orsco Laboratoire Veterinaire

⚠️ Moderate Risk

FEI: 3008559467 • Neyron, AIN • FRANCE

FEI

FEI Number

3008559467

📍

Location

Neyron, AIN

🇫🇷

Country

FRANCE
🏢

Address

14 Zi Porte Du Grand Lyon, , Neyron, AIN, France

Moderate Risk

FDA Import Risk Assessment

40.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/18/2012
Latest Refusal
1/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
13.8×10%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

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
6/18/2012
72YGT99PET/LAB ANIMAL FOOD, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
1/5/2011
68YYF20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
72NEW VET DR
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Orsco Laboratoire Veterinaire's FDA import refusal history?

Orsco Laboratoire Veterinaire (FEI: 3008559467) has 2 FDA import refusal record(s) in our database, spanning from 1/5/2011 to 6/18/2012.

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. Orsco Laboratoire Veterinaire's FEI number is 3008559467.

What types of violations has Orsco Laboratoire Veterinaire received?

Orsco Laboratoire Veterinaire 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 Orsco Laboratoire Veterinaire come from?

All FDA import refusal data for Orsco Laboratoire Veterinaire 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.