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SHANDONG SHY CLOUD TECH CO

⚠️ Moderate Risk

FEI: 3016162325 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3016162325

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Bldg A 289 No 2, Qingpu, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/8/2021
Latest Refusal
1/8/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
1/8/2021
80MQXNEEDLE, ACUPUNCTURE, SINGLE USE
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANDONG SHY CLOUD TECH CO's FDA import refusal history?

SHANDONG SHY CLOUD TECH CO (FEI: 3016162325) has 1 FDA import refusal record(s) in our database, spanning from 1/8/2021 to 1/8/2021.

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. SHANDONG SHY CLOUD TECH CO's FEI number is 3016162325.

What types of violations has SHANDONG SHY CLOUD TECH CO received?

SHANDONG SHY CLOUD TECH CO 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 SHANDONG SHY CLOUD TECH CO come from?

All FDA import refusal data for SHANDONG SHY CLOUD TECH CO 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.