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ZHANG PU SHANG SHUN OPTICAL INDUSTR

✅ Low Risk

FEI: 3013412380 • Fujian • CHINA

FEI

FEI Number

3013412380

📍

Location

Fujian

🇨🇳

Country

CHINA
🏢

Address

Suin-An Gong Ye Kaifa Qu, , Fujian, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
10/17/2017
Latest Refusal
10/17/2017
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
10/17/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3280FRNMFGREG
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is ZHANG PU SHANG SHUN OPTICAL INDUSTR's FDA import refusal history?

ZHANG PU SHANG SHUN OPTICAL INDUSTR (FEI: 3013412380) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2017 to 10/17/2017.

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. ZHANG PU SHANG SHUN OPTICAL INDUSTR's FEI number is 3013412380.

What types of violations has ZHANG PU SHANG SHUN OPTICAL INDUSTR received?

ZHANG PU SHANG SHUN OPTICAL INDUSTR 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 ZHANG PU SHANG SHUN OPTICAL INDUSTR come from?

All FDA import refusal data for ZHANG PU SHANG SHUN OPTICAL INDUSTR 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.