NEW ERA ENTERPRISE CO.,LTD.

⚠️ High Risk

FEI: 3017808372 • Tainan City • TAIWAN

FEI

FEI Number

3017808372

📍

Location

Tainan City

🇹🇼

Country

TAIWAN

🏢

Address

No.142-1 Zhengyi 3rd St.,, Rende District, Tainan City, , Taiwan

High Risk

FDA Import Risk Assessment

63.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/14/2025

Latest Refusal

9/17/2021

Earliest Refusal

Score Breakdown

Violation Severity

59.7×40%

Refusal Volume

49.7×30%

Recency

95.2×20%

Frequency

51.5×10%

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

23520×

NOT IMPACT

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

23112×

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.

4731×

LABELING

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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

Date	Product	Violations	Division
10/14/2025	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southeast Imports (DSEI)
2/3/2022	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of West Coast Imports (DWCI)
2/3/2022	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of West Coast Imports (DWCI)
2/3/2022	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of West Coast Imports (DWCI)
2/3/2022	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of West Coast Imports (DWCI)
12/7/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of West Coast Imports (DWCI)
12/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
12/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
11/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
11/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
11/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
11/2/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)
11/1/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	479DV QUALITY	Division of Southwest Imports (DSWI)
11/1/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
11/1/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
10/18/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT 473LABELING	Division of Southwest Imports (DSWI)
10/18/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
10/18/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
10/14/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
10/14/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Division of Southwest Imports (DSWI)
9/17/2021	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	231LENS CERT 235NOT IMPACT	Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is NEW ERA ENTERPRISE CO.,LTD.'s FDA import refusal history?

NEW ERA ENTERPRISE CO.,LTD. (FEI: 3017808372) has 21 FDA import refusal record(s) in our database, spanning from 9/17/2021 to 10/14/2025.

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. NEW ERA ENTERPRISE CO.,LTD.'s FEI number is 3017808372.

What types of violations has NEW ERA ENTERPRISE CO.,LTD. received?

NEW ERA ENTERPRISE CO.,LTD. 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 NEW ERA ENTERPRISE CO.,LTD. come from?

All FDA import refusal data for NEW ERA ENTERPRISE CO.,LTD. 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.