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NINGBO YIHE HI TECH CO LTS

⚠️ Moderate Risk

FEI: 3014421640 • Zhejiang • CHINA

FEI

FEI Number

3014421640

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No 156 Laixun Rd Danxi, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/27/2018
Latest Refusal
7/27/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

161×

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.

751×

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).

Refusal History

DateProductViolationsDivision
7/27/2018
60TCK14NALOXONE HCL (ANTAGONIST)
16DIRECTIONS
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NINGBO YIHE HI TECH CO LTS's FDA import refusal history?

NINGBO YIHE HI TECH CO LTS (FEI: 3014421640) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2018 to 7/27/2018.

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. NINGBO YIHE HI TECH CO LTS's FEI number is 3014421640.

What types of violations has NINGBO YIHE HI TECH CO LTS received?

NINGBO YIHE HI TECH CO LTS 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 YIHE HI TECH CO LTS come from?

All FDA import refusal data for NINGBO YIHE HI TECH CO LTS 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.