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Taizhou Xinzhixaun Daily Use Co Ltd

✅ Low Risk

FEI: 3008318714 • Taizhou • CHINA

FEI

FEI Number

3008318714

📍

Location

Taizhou

🇨🇳

Country

CHINA
🏢

Address

North, No. 36 Kangqiang Road; City Development Zone Huangyan, Taizhou, , China

Low Risk

FDA Import Risk Assessment

19.0
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
10/1/2014
Latest Refusal
10/1/2014
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
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

1181×

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
10/1/2014
66YCL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
333LACKS FIRM
473LABELING
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Taizhou Xinzhixaun Daily Use Co Ltd's FDA import refusal history?

Taizhou Xinzhixaun Daily Use Co Ltd (FEI: 3008318714) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2014 to 10/1/2014.

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. Taizhou Xinzhixaun Daily Use Co Ltd's FEI number is 3008318714.

What types of violations has Taizhou Xinzhixaun Daily Use Co Ltd received?

Taizhou Xinzhixaun Daily Use Co Ltd has been cited for 3 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 Taizhou Xinzhixaun Daily Use Co Ltd come from?

All FDA import refusal data for Taizhou Xinzhixaun Daily Use 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.