Ningbo Cstar Import& Export Co., Ltd

⚠️ Moderate Risk

FEI: 3009399540 • Ningbo • CHINA

FEI

FEI Number

3009399540

📍

Location

Ningbo

🇨🇳

Country

CHINA

🏢

Address

8 Fl, Hengyuan Bldg, N.568 Tiantong, , Ningbo, , China

Moderate Risk

FDA Import Risk Assessment

46.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/26/2013

Latest Refusal

2/19/2013

Earliest Refusal

Score Breakdown

Violation Severity

59.6×40%

Refusal Volume

41.3×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11812×

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).

1611×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

Date	Product	Violations	Division
9/26/2013	62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL)	118NOT LISTED	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/19/2013	64ABL99DISINFECTANT N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Ningbo Cstar Import& Export Co., Ltd's FDA import refusal history?

Ningbo Cstar Import& Export Co., Ltd (FEI: 3009399540) has 12 FDA import refusal record(s) in our database, spanning from 2/19/2013 to 9/26/2013.

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. Ningbo Cstar Import& Export Co., Ltd's FEI number is 3009399540.

What types of violations has Ningbo Cstar Import& Export Co., Ltd received?

Ningbo Cstar Import& Export 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 Ningbo Cstar Import& Export Co., Ltd come from?

All FDA import refusal data for Ningbo Cstar Import& Export 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.