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12m 16 Bis

⚠️ Moderate Risk

FEI: 3003614118 • Caen Cedex • FRANCE

FEI

FEI Number

3003614118

📍

Location

Caen Cedex

🇫🇷

Country

FRANCE
🏢

Address

Bp 200 14011, Fosses Saint Julien, Caen Cedex, , France

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/9/2002
Latest Refusal
4/9/2002
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
4/9/2002
89EGJDEVICE, IONTOPHORESIS, OTHER USES
2380NO PMA/PDP
84RX DEVICE
New York District Office (NYK-DO)

Frequently Asked Questions

What is 12m 16 Bis's FDA import refusal history?

12m 16 Bis (FEI: 3003614118) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2002 to 4/9/2002.

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. 12m 16 Bis's FEI number is 3003614118.

What types of violations has 12m 16 Bis received?

12m 16 Bis 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 12m 16 Bis come from?

All FDA import refusal data for 12m 16 Bis 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.