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Borrion Great Enterprise Wenzhou

⚠️ High Risk

FEI: 3011629143 • Wenzhou Zhejian • CHINA

FEI

FEI Number

3011629143

📍

Location

Wenzhou Zhejian

🇨🇳

Country

CHINA
🏢

Address

Xingguo Rd Tech Park NO 8, , Wenzhou Zhejian, , China

High Risk

FDA Import Risk Assessment

51.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
3
Unique Violations
11/1/2022
Latest Refusal
10/17/2019
Earliest Refusal

Score Breakdown

Violation Severity
58.5×40%
Refusal Volume
48.2×30%
Recency
36.1×20%
Frequency
62.4×10%
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

23118×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
11/1/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of West Coast Imports (DWCI)
10/17/2019
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Borrion Great Enterprise Wenzhou's FDA import refusal history?

Borrion Great Enterprise Wenzhou (FEI: 3011629143) has 19 FDA import refusal record(s) in our database, spanning from 10/17/2019 to 11/1/2022.

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. Borrion Great Enterprise Wenzhou's FEI number is 3011629143.

What types of violations has Borrion Great Enterprise Wenzhou received?

Borrion Great Enterprise Wenzhou 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 Borrion Great Enterprise Wenzhou come from?

All FDA import refusal data for Borrion Great Enterprise Wenzhou 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.