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Frances Denis Lab

✅ Low Risk

FEI: 3005337481 • Espa A Spain • FRANCE

FEI

FEI Number

3005337481

📍

Location

Espa A Spain

🇫🇷

Country

FRANCE
🏢

Address

Barcelona, , Espa A Spain, , France

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/24/2005
Latest Refusal
10/24/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
10/24/2005
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Frances Denis Lab's FDA import refusal history?

Frances Denis Lab (FEI: 3005337481) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 10/24/2005.

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. Frances Denis Lab's FEI number is 3005337481.

What types of violations has Frances Denis Lab received?

Frances Denis Lab 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 Frances Denis Lab come from?

All FDA import refusal data for Frances Denis Lab 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.