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Cj Haide (Ningbo) Biotech Co., Ltd

⚠️ Moderate Risk

FEI: 3004248889 • Ningbo, Zheijang • CHINA

FEI

FEI Number

3004248889

📍

Location

Ningbo, Zheijang

🇨🇳

Country

CHINA
🏢

Address

799 Fengxiang Rd, Xiepu, Ningbo, Zheijang, China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/3/2011
Latest Refusal
2/3/2011
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
2/3/2011
57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
118NOT LISTED
2280DIRSEXMPT
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Cj Haide (Ningbo) Biotech Co., Ltd's FDA import refusal history?

Cj Haide (Ningbo) Biotech Co., Ltd (FEI: 3004248889) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2011 to 2/3/2011.

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. Cj Haide (Ningbo) Biotech Co., Ltd's FEI number is 3004248889.

What types of violations has Cj Haide (Ningbo) Biotech Co., Ltd received?

Cj Haide (Ningbo) Biotech 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 Cj Haide (Ningbo) Biotech Co., Ltd come from?

All FDA import refusal data for Cj Haide (Ningbo) Biotech 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.