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Pharmaceutical Laboratory Michel Id

⚠️ High Risk

FEI: 3007512931 • Rosheim, Bas Rhin • FRANCE

FEI

FEI Number

3007512931

📍

Location

Rosheim, Bas Rhin

🇫🇷

Country

FRANCE
🏢

Address

1 Parc D Activites du Rosenmeer, , Rosheim, Bas Rhin, France

High Risk

FDA Import Risk Assessment

58.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
1/21/2025
Latest Refusal
1/21/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
75.7×20%
Frequency
20.0×10%
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

752×

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
1/21/2025
62HCY03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/21/2025
56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pharmaceutical Laboratory Michel Id's FDA import refusal history?

Pharmaceutical Laboratory Michel Id (FEI: 3007512931) has 2 FDA import refusal record(s) in our database, spanning from 1/21/2025 to 1/21/2025.

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. Pharmaceutical Laboratory Michel Id's FEI number is 3007512931.

What types of violations has Pharmaceutical Laboratory Michel Id received?

Pharmaceutical Laboratory Michel Id has been cited for 1 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 Pharmaceutical Laboratory Michel Id come from?

All FDA import refusal data for Pharmaceutical Laboratory Michel Id 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.