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Xiantao Tongda Non-woven Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3011511692 • Huanggang, Hubei • CHINA

FEI

FEI Number

3011511692

📍

Location

Huanggang, Hubei

🇨🇳

Country

CHINA
🏢

Address

South Of Xiansha Road, Peng Changzhen Xiantao, Huanggang, Hubei, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/9/2021
Latest Refusal
6/9/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
6/9/2021
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
2780DEVICEGMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Xiantao Tongda Non-woven Products Co., Ltd.'s FDA import refusal history?

Xiantao Tongda Non-woven Products Co., Ltd. (FEI: 3011511692) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2021 to 6/9/2021.

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. Xiantao Tongda Non-woven Products Co., Ltd.'s FEI number is 3011511692.

What types of violations has Xiantao Tongda Non-woven Products Co., Ltd. received?

Xiantao Tongda Non-woven Products 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 Xiantao Tongda Non-woven Products Co., Ltd. come from?

All FDA import refusal data for Xiantao Tongda Non-woven Products 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.