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Lurer, Michael

⚠️ Moderate Risk

FEI: 3004496505 • Banpain Ayuthaya • THAILAND

FEI

FEI Number

3004496505

📍

Location

Banpain Ayuthaya

🇹🇭

Country

THAILAND
🏢

Address

26 Moo1 U-Domsorrarut Rd, , Banpain Ayuthaya, , Thailand

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/21/2004
Latest Refusal
4/21/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
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
4/21/2004
61PAA55METFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/21/2004
56BAA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Lurer, Michael's FDA import refusal history?

Lurer, Michael (FEI: 3004496505) has 2 FDA import refusal record(s) in our database, spanning from 4/21/2004 to 4/21/2004.

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. Lurer, Michael's FEI number is 3004496505.

What types of violations has Lurer, Michael received?

Lurer, Michael 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 Lurer, Michael come from?

All FDA import refusal data for Lurer, Michael 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.