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Novorate Biotech

✅ Low Risk

FEI: 3010742646 • Huzhou City • CHINA

FEI

FEI Number

3010742646

📍

Location

Huzhou City

🇨🇳

Country

CHINA
🏢

Address

No 281, Xinshi Industrial Park, , Huzhou City, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/5/2014
Latest Refusal
12/5/2014
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
12/5/2014
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
223FALSE
335LACKS N/C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novorate Biotech's FDA import refusal history?

Novorate Biotech (FEI: 3010742646) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2014 to 12/5/2014.

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. Novorate Biotech's FEI number is 3010742646.

What types of violations has Novorate Biotech received?

Novorate Biotech 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 Novorate Biotech come from?

All FDA import refusal data for Novorate Biotech 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.