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Hebei Xingyu Chemical Co., Ltd.

⚠️ Moderate Risk

FEI: 3007218320 • Luquan City, Hebeisheng • CHINA

FEI

FEI Number

3007218320

📍

Location

Luquan City, Hebeisheng

🇨🇳

Country

CHINA
🏢

Address

Shijing Countryside, , Luquan City, Hebeisheng, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/3/2014
Latest Refusal
11/3/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

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
11/3/2014
89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC
260FALSE
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hebei Xingyu Chemical Co., Ltd.'s FDA import refusal history?

Hebei Xingyu Chemical Co., Ltd. (FEI: 3007218320) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2014 to 11/3/2014.

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. Hebei Xingyu Chemical Co., Ltd.'s FEI number is 3007218320.

What types of violations has Hebei Xingyu Chemical Co., Ltd. received?

Hebei Xingyu Chemical Co., Ltd. has been cited for 2 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 Hebei Xingyu Chemical Co., Ltd. come from?

All FDA import refusal data for Hebei Xingyu 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.