Lf Fashion

⚠️ Moderate Risk

FEI: 3011824075 • Dongguangdongguang • CHINA

FEI

FEI Number

3011824075

📍

Location

Dongguangdongguang

🇨🇳

Country

CHINA

🏢

Address

Hing Ngai Leatherware Factory, Chang An, , Dongguangdongguang, , China

Moderate Risk

FDA Import Risk Assessment

37.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/10/2015

Latest Refusal

12/4/2015

Earliest Refusal

Score Breakdown

Violation Severity

43.3×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

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

Violation Summary

3415×

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).

2313×

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.

Refusal History

Date	Product	Violations	Division
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	341REGISTERED	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT	Division of Northeast Imports (DNEI)
12/10/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT	Division of Northeast Imports (DNEI)
12/4/2015	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	New York District Office (NYK-DO)

Frequently Asked Questions

What is Lf Fashion's FDA import refusal history?

Lf Fashion (FEI: 3011824075) has 9 FDA import refusal record(s) in our database, spanning from 12/4/2015 to 12/10/2015.

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. Lf Fashion's FEI number is 3011824075.

What types of violations has Lf Fashion received?

Lf Fashion 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 Lf Fashion come from?

All FDA import refusal data for Lf Fashion 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.