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Biochem Pacific Import & Export Ltd

⚠️ Moderate Risk

FEI: 3005249249 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3005249249

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Cheng Jian Tower, 189 Tiyu West Rd, Guangzhou, Guangdong, China

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
8/12/2005
Latest Refusal
8/12/2005
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
8/12/2005
56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Biochem Pacific Import & Export Ltd's FDA import refusal history?

Biochem Pacific Import & Export Ltd (FEI: 3005249249) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2005 to 8/12/2005.

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. Biochem Pacific Import & Export Ltd's FEI number is 3005249249.

What types of violations has Biochem Pacific Import & Export Ltd received?

Biochem Pacific Import & Export 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 Biochem Pacific Import & Export Ltd come from?

All FDA import refusal data for Biochem Pacific Import & Export 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.