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Heng Yuan Biotechnology Co., Ltd.

🚨 Critical Risk

FEI: 3016408866 β€’ Zhaoyuan City, Shandong β€’ CHINA

FEI

FEI Number

3016408866

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Location

Zhaoyuan City, Shandong

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Country

CHINA
🏒

Address

No. 68 Hengyuan Road, Yantai City, Zhaoyuan City, Shandong, China

Critical Risk

FDA Import Risk Assessment

81.3
LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

16
Total Refusals
1
Unique Violations
10/23/2025
Latest Refusal
12/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
100.0Γ—40%
Refusal Volume
45.6Γ—30%
Recency
95.3Γ—20%
Frequency
85.8Γ—10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity β€” AI-assessed (1-10)
  • 30% Refusal Volume β€” Logarithmic scale
  • 20% Recency β€” Decays over 5 years
  • 10% Frequency β€” Refusals per year

Β© ImportRefusal.com Original Analysis

Violation Summary

342116Γ—

MELAMINE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.

Refusal History

DateProductViolationsDivision
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
10/23/2025
18YGY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)
8/7/2025
18YBR99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of Northern Border Imports (DNBI)
12/12/2023
18YGT99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
3421MELAMINE
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Heng Yuan Biotechnology Co., Ltd.'s FDA import refusal history?

Heng Yuan Biotechnology Co., Ltd. (FEI: 3016408866) has 16 FDA import refusal record(s) in our database, spanning from 12/12/2023 to 10/23/2025.

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. Heng Yuan Biotechnology Co., Ltd.'s FEI number is 3016408866.

What types of violations has Heng Yuan Biotechnology Co., Ltd. received?

Heng Yuan Biotechnology 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 Heng Yuan Biotechnology Co., Ltd. come from?

All FDA import refusal data for Heng Yuan Biotechnology 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.