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TIANAN ENVIRONMENT TECHNOLOGY CO

Low Risk

FEI: 3017195358 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3017195358

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Longgang Road, Longgangjiedao Longgang, Shenzhen, Guangdong, 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
4
Unique Violations
9/14/2020
Latest Refusal
9/14/2020
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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
9/14/2020
89KNMDEVICE, PRESSURE APPLYING
118NOT LISTED
223FALSE
3280FRNMFGREG
333LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TIANAN ENVIRONMENT TECHNOLOGY CO's FDA import refusal history?

TIANAN ENVIRONMENT TECHNOLOGY CO (FEI: 3017195358) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2020 to 9/14/2020.

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. TIANAN ENVIRONMENT TECHNOLOGY CO's FEI number is 3017195358.

What types of violations has TIANAN ENVIRONMENT TECHNOLOGY CO received?

TIANAN ENVIRONMENT TECHNOLOGY CO has been cited for 4 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 TIANAN ENVIRONMENT TECHNOLOGY CO come from?

All FDA import refusal data for TIANAN ENVIRONMENT TECHNOLOGY CO 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.