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SHANDONG AOCTER CHEMICAL CO., LTD.

⚠️ Moderate Risk

FEI: 3013110617 • Liaocheng, Shandong • CHINA

FEI

FEI Number

3013110617

📍

Location

Liaocheng, Shandong

🇨🇳

Country

CHINA
🏢

Address

No. 5 Guandao North Rd, Cheng Gaotangxian, Liaocheng, Shandong, China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/18/2015
Latest Refusal
8/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
8/18/2015
65CAR04BETAINE ANHYDROUS (NUTRIENT/TONIC)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is SHANDONG AOCTER CHEMICAL CO., LTD.'s FDA import refusal history?

SHANDONG AOCTER CHEMICAL CO., LTD. (FEI: 3013110617) has 1 FDA import refusal record(s) in our database, spanning from 8/18/2015 to 8/18/2015.

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 AOCTER CHEMICAL CO., LTD.'s FEI number is 3013110617.

What types of violations has SHANDONG AOCTER CHEMICAL CO., LTD. received?

SHANDONG AOCTER 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 SHANDONG AOCTER CHEMICAL CO., LTD. come from?

All FDA import refusal data for SHANDONG AOCTER 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.