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SHANDONG INTCO RECYCLING RESOURCES CO., LTD.

⚠️ Moderate Risk

FEI: 3011638934 • Zibo, Shandong • CHINA

FEI

FEI Number

3011638934

📍

Location

Zibo, Shandong

🇨🇳

Country

CHINA
🏢

Address

18 Qingtian Road, Linzi, Zibo, Shandong, China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/5/2021
Latest Refusal
3/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
3/5/2021
80OEANON-SURGICAL ISOLATION GOWN
118NOT LISTED
Division of Northern Border Imports (DNBI)
3/5/2021
80OEANON-SURGICAL ISOLATION GOWN
118NOT LISTED
Division of Northern Border Imports (DNBI)
3/5/2021
80OEANON-SURGICAL ISOLATION GOWN
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SHANDONG INTCO RECYCLING RESOURCES CO., LTD.'s FDA import refusal history?

SHANDONG INTCO RECYCLING RESOURCES CO., LTD. (FEI: 3011638934) has 3 FDA import refusal record(s) in our database, spanning from 3/5/2021 to 3/5/2021.

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 INTCO RECYCLING RESOURCES CO., LTD.'s FEI number is 3011638934.

What types of violations has SHANDONG INTCO RECYCLING RESOURCES CO., LTD. received?

SHANDONG INTCO RECYCLING RESOURCES 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 SHANDONG INTCO RECYCLING RESOURCES CO., LTD. come from?

All FDA import refusal data for SHANDONG INTCO RECYCLING RESOURCES 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.