ImportRefusal LogoImportRefusal

SHENZHEN CALTETO TRADING CO LTD

✅ Low Risk

FEI: 3012597346 • HONG KONG • CHINA

FEI

FEI Number

3012597346

📍

Location

HONG KONG

🇨🇳

Country

CHINA
🏢

Address

RM D9 2 F KOON WO IND B, , HONG KONG, , 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
1
Unique Violations
8/26/2016
Latest Refusal
8/26/2016
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

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).

Refusal History

DateProductViolationsDivision
8/26/2016
76PMEEXTERNAL CLEANING SOLUTION
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is SHENZHEN CALTETO TRADING CO LTD's FDA import refusal history?

SHENZHEN CALTETO TRADING CO LTD (FEI: 3012597346) has 1 FDA import refusal record(s) in our database, spanning from 8/26/2016 to 8/26/2016.

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 CALTETO TRADING CO LTD's FEI number is 3012597346.

What types of violations has SHENZHEN CALTETO TRADING CO LTD received?

SHENZHEN CALTETO TRADING CO LTD has been cited for 1 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 CALTETO TRADING CO LTD come from?

All FDA import refusal data for SHENZHEN CALTETO TRADING 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.