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Shandong Kaiyuan Group Corp.

⚠️ Moderate Risk

FEI: 1000578981 • Weifong, Shandong • CHINA

FEI

FEI Number

1000578981

📍

Location

Weifong, Shandong

🇨🇳

Country

CHINA
🏢

Address

88 Minshengdong St., , Weifong, Shandong, China

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/12/2011
Latest Refusal
6/22/2009
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
13.0×10%
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

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/12/2011
37BCP31BEAN CURD PASTE, (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS
249FILTHY
Los Angeles District Office (LOS-DO)
6/22/2009
37JCP05SOY SAUCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
6/22/2009
37JEP05SOY SAUCE
62NEEDS FCE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shandong Kaiyuan Group Corp.'s FDA import refusal history?

Shandong Kaiyuan Group Corp. (FEI: 1000578981) has 3 FDA import refusal record(s) in our database, spanning from 6/22/2009 to 10/12/2011.

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. Shandong Kaiyuan Group Corp.'s FEI number is 1000578981.

What types of violations has Shandong Kaiyuan Group Corp. received?

Shandong Kaiyuan Group Corp. has been cited for 3 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 Shandong Kaiyuan Group Corp. come from?

All FDA import refusal data for Shandong Kaiyuan Group 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.