ImportRefusal LogoImportRefusal

Shenzhen Sailebao Tech Co Ltd

⚠️ Moderate Risk

FEI: 3007086380 • Baoanbaoan • CHINA

FEI

FEI Number

3007086380

📍

Location

Baoanbaoan

🇨🇳

Country

CHINA
🏢

Address

3f C2 4 Buildingshasan Chuang Ind Park, , Baoanbaoan, , China

Moderate Risk

FDA Import Risk Assessment

48.9
LowModerateHighCritical

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

Statistics

8
Total Refusals
3
Unique Violations
6/23/2010
Latest Refusal
3/19/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
63.3×10%
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

757×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

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).

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
6/23/2010
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/23/2010
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/23/2010
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/17/2009
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/5/2009
66BBY44NICOTINE DELIVERY SYSTEM
473LABELING
Philadelphia District Office (PHI-DO)
4/28/2009
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/10/2009
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)
3/19/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shenzhen Sailebao Tech Co Ltd's FDA import refusal history?

Shenzhen Sailebao Tech Co Ltd (FEI: 3007086380) has 8 FDA import refusal record(s) in our database, spanning from 3/19/2009 to 6/23/2010.

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. Shenzhen Sailebao Tech Co Ltd's FEI number is 3007086380.

What types of violations has Shenzhen Sailebao Tech Co Ltd received?

Shenzhen Sailebao Tech 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 Shenzhen Sailebao Tech Co Ltd come from?

All FDA import refusal data for Shenzhen Sailebao Tech 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.