ImportRefusal LogoImportRefusal

SHENZHEN TI JIEKANG ENERGY SAVIN

Low Risk

FEI: 3014585225 • Shenzhen • CHINA

FEI

FEI Number

3014585225

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

East Longxing Science T, , Shenzhen, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/30/2018
Latest Refusal
9/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
9/30/2018
76ELAINSTRUMENT, HAND, CALCULUS REMOVAL
118NOT LISTED
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN TI JIEKANG ENERGY SAVIN's FDA import refusal history?

SHENZHEN TI JIEKANG ENERGY SAVIN (FEI: 3014585225) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2018 to 9/30/2018.

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 TI JIEKANG ENERGY SAVIN's FEI number is 3014585225.

What types of violations has SHENZHEN TI JIEKANG ENERGY SAVIN received?

SHENZHEN TI JIEKANG ENERGY SAVIN 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 SHENZHEN TI JIEKANG ENERGY SAVIN come from?

All FDA import refusal data for SHENZHEN TI JIEKANG ENERGY SAVIN 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.