ImportRefusal LogoImportRefusal

Bangkok Lab And Cosmetic Ltd

⚠️ Moderate Risk

FEI: 3005544486 • Rajthevee • THAILAND

FEI

FEI Number

3005544486

📍

Location

Rajthevee

🇹🇭

Country

THAILAND
🏢

Address

874 Soi 23 Rama 6rd, , Rajthevee, , Thailand

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/15/2010
Latest Refusal
11/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
11/15/2010
56JCE20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bangkok Lab And Cosmetic Ltd's FDA import refusal history?

Bangkok Lab And Cosmetic Ltd (FEI: 3005544486) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2010 to 11/15/2010.

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. Bangkok Lab And Cosmetic Ltd's FEI number is 3005544486.

What types of violations has Bangkok Lab And Cosmetic Ltd received?

Bangkok Lab And Cosmetic Ltd 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 Bangkok Lab And Cosmetic Ltd come from?

All FDA import refusal data for Bangkok Lab And Cosmetic Ltd 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.