ImportRefusal LogoImportRefusal

Shuyu Co. Ltd.

⚠️ Moderate Risk

FEI: 3001718238 • Sabae, Fukui • JAPAN

FEI

FEI Number

3001718238

📍

Location

Sabae, Fukui

🇯🇵

Country

JAPAN
🏢

Address

16-26-1, Yokogoshi-Cho, Sabae, Fukui, Japan

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
1
Unique Violations
1/26/2010
Latest Refusal
1/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

23110×

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.

Refusal History

DateProductViolationsDivision
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)
1/26/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Shuyu Co. Ltd.'s FDA import refusal history?

Shuyu Co. Ltd. (FEI: 3001718238) has 10 FDA import refusal record(s) in our database, spanning from 1/26/2010 to 1/26/2010.

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. Shuyu Co. Ltd.'s FEI number is 3001718238.

What types of violations has Shuyu Co. Ltd. received?

Shuyu Co. Ltd. has been cited for 1 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 Shuyu Co. Ltd. come from?

All FDA import refusal data for Shuyu 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.