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ZHENG ZHOU PZ SLIM TECHNOLOGY CO

⚠️ Moderate Risk

FEI: 3015120074 • Zhengzhou • CHINA

FEI

FEI Number

3015120074

📍

Location

Zhengzhou

🇨🇳

Country

CHINA
🏢

Address

Room 201, Floor 2nd Buil, Zhengzhou, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/27/2019
Latest Refusal
2/27/2019
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1181×

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).

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
2/27/2019
89LYGMASSAGER, THERAPEUTIC, MANUAL
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ZHENG ZHOU PZ SLIM TECHNOLOGY CO's FDA import refusal history?

ZHENG ZHOU PZ SLIM TECHNOLOGY CO (FEI: 3015120074) has 1 FDA import refusal record(s) in our database, spanning from 2/27/2019 to 2/27/2019.

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. ZHENG ZHOU PZ SLIM TECHNOLOGY CO's FEI number is 3015120074.

What types of violations has ZHENG ZHOU PZ SLIM TECHNOLOGY CO received?

ZHENG ZHOU PZ SLIM TECHNOLOGY CO 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 ZHENG ZHOU PZ SLIM TECHNOLOGY CO come from?

All FDA import refusal data for ZHENG ZHOU PZ SLIM TECHNOLOGY 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.