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Sinochem Hebei Import Export Corp

✅ Low Risk

FEI: 3002715546 • Shijiahuang • CHINA

FEI

FEI Number

3002715546

📍

Location

Shijiahuang

🇨🇳

Country

CHINA
🏢

Address

707 Lianmeng Rd, , Shijiahuang, , 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
2
Unique Violations
12/10/2004
Latest Refusal
12/10/2004
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/10/2004
80FMFSYRINGE, PISTON
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sinochem Hebei Import Export Corp's FDA import refusal history?

Sinochem Hebei Import Export Corp (FEI: 3002715546) has 1 FDA import refusal record(s) in our database, spanning from 12/10/2004 to 12/10/2004.

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. Sinochem Hebei Import Export Corp's FEI number is 3002715546.

What types of violations has Sinochem Hebei Import Export Corp received?

Sinochem Hebei Import Export Corp 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 Sinochem Hebei Import Export Corp come from?

All FDA import refusal data for Sinochem Hebei Import Export Corp 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.