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Rayto Life And Analytical Sciences Co., Ltd.

⚠️ Moderate Risk

FEI: 3005619668 • Shenzhen • CHINA

FEI

FEI Number

3005619668

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

A/6f, Technology Building, Industrial Rd, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/15/2006
Latest Refusal
11/15/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
11/15/2006
75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
118NOT LISTED
Division of Southeast Imports (DSEI)
11/15/2006
75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Rayto Life And Analytical Sciences Co., Ltd.'s FDA import refusal history?

Rayto Life And Analytical Sciences Co., Ltd. (FEI: 3005619668) has 2 FDA import refusal record(s) in our database, spanning from 11/15/2006 to 11/15/2006.

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. Rayto Life And Analytical Sciences Co., Ltd.'s FEI number is 3005619668.

What types of violations has Rayto Life And Analytical Sciences Co., Ltd. received?

Rayto Life And Analytical Sciences 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 Rayto Life And Analytical Sciences Co., Ltd. come from?

All FDA import refusal data for Rayto Life And Analytical Sciences 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.