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Huzhou Tulip Medical Equipment Co

✅ Low Risk

FEI: 3007857032 • Huzhou Cityhuzhou City • CHINA

FEI

FEI Number

3007857032

📍

Location

Huzhou Cityhuzhou City

🇨🇳

Country

CHINA
🏢

Address

No. 40, Building 5fumiao, , Huzhou Cityhuzhou City, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/30/2009
Latest Refusal
9/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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).

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
9/30/2009
54FBE12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
118NOT LISTED
336INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Huzhou Tulip Medical Equipment Co's FDA import refusal history?

Huzhou Tulip Medical Equipment Co (FEI: 3007857032) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2009 to 9/30/2009.

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. Huzhou Tulip Medical Equipment Co's FEI number is 3007857032.

What types of violations has Huzhou Tulip Medical Equipment Co received?

Huzhou Tulip Medical Equipment Co 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 Huzhou Tulip Medical Equipment Co come from?

All FDA import refusal data for Huzhou Tulip Medical Equipment Co 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.