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Xinxiang Huaxing Chemical Co., Ltd.

✅ Low Risk

FEI: 3010312423 • Xinxiang, Henan • CHINA

FEI

FEI Number

3010312423

📍

Location

Xinxiang, Henan

🇨🇳

Country

CHINA
🏢

Address

Xiaokuai Village, Dakuai Town, Fengquan District, Xinxiang, Henan, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/2/2013
Latest Refusal
8/2/2013
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/2/2013
56JCT30LINCOMYCIN HYDROCHLORIDE MONOHYDRATE (LINCOMYCINS)
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Xinxiang Huaxing Chemical Co., Ltd.'s FDA import refusal history?

Xinxiang Huaxing Chemical Co., Ltd. (FEI: 3010312423) has 1 FDA import refusal record(s) in our database, spanning from 8/2/2013 to 8/2/2013.

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. Xinxiang Huaxing Chemical Co., Ltd.'s FEI number is 3010312423.

What types of violations has Xinxiang Huaxing Chemical Co., Ltd. received?

Xinxiang Huaxing Chemical Co., 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 Xinxiang Huaxing Chemical Co., Ltd. come from?

All FDA import refusal data for Xinxiang Huaxing Chemical Co., 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.