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Southwest Pharmaceutical

⚠️ Moderate Risk

FEI: 1000263197 • Chongging • CHINA

FEI

FEI Number

1000263197

📍

Location

Chongging

🇨🇳

Country

CHINA
🏢

Address

Add No. 129 Wuyi Road, , Chongging, , China

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

2
Total Refusals
1
Unique Violations
9/1/2006
Latest Refusal
9/26/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
10.3×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
9/1/2006
62GCS46KETOPROFEN (ANTI-INFLAMMATORY)
16DIRECTIONS
New York District Office (NYK-DO)
9/26/2004
61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Southwest Pharmaceutical's FDA import refusal history?

Southwest Pharmaceutical (FEI: 1000263197) has 2 FDA import refusal record(s) in our database, spanning from 9/26/2004 to 9/1/2006.

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. Southwest Pharmaceutical's FEI number is 1000263197.

What types of violations has Southwest Pharmaceutical received?

Southwest Pharmaceutical 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 Southwest Pharmaceutical come from?

All FDA import refusal data for Southwest Pharmaceutical 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.