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ACE Biotechnology Co., Ltd.

⚠️ Moderate Risk

FEI: 3014154318 • Xiangtan, Hunan • CHINA

FEI

FEI Number

3014154318

📍

Location

Xiangtan, Hunan

🇨🇳

Country

CHINA
🏢

Address

Yulong Rd, Tianyi Demonstration Zone, Xiangtan, Hunan, China

Moderate Risk

FDA Import Risk Assessment

44.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/3/2022
Latest Refusal
11/3/2022
Earliest Refusal

Score Breakdown

Violation Severity
76.0×40%
Refusal Volume
22.3×30%
Recency
21.1×20%
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

2493×

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.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
11/3/2022
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
473LABELING
Division of West Coast Imports (DWCI)
11/3/2022
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
473LABELING
Division of West Coast Imports (DWCI)
11/3/2022
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)

Frequently Asked Questions

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

ACE Biotechnology Co., Ltd. (FEI: 3014154318) has 3 FDA import refusal record(s) in our database, spanning from 11/3/2022 to 11/3/2022.

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. ACE Biotechnology Co., Ltd.'s FEI number is 3014154318.

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

ACE Biotechnology Co., Ltd. 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 ACE Biotechnology Co., Ltd. come from?

All FDA import refusal data for ACE 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.