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PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD.

✅ Low Risk

FEI: 3016727036 • Puning, Guangdong • CHINA

FEI

FEI Number

3016727036

📍

Location

Puning, Guangdong

🇨🇳

Country

CHINA
🏢

Address

East Of Xinjin Township Gate, Wushi Village, Liaoyuan Street, Puning, Guangdong, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/9/2020
Latest Refusal
7/9/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
7/9/2020
80OUKSURGICAL MASK WITH ANTIMICROBIAL/ANTIVIRAL AGENT
341REGISTERED
479DV QUALITY
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD.'s FDA import refusal history?

PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD. (FEI: 3016727036) has 1 FDA import refusal record(s) in our database, spanning from 7/9/2020 to 7/9/2020.

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. PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD.'s FEI number is 3016727036.

What types of violations has PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD. received?

PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD. 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 PUNING JIANSHUN PROTECTIVE PRODUCTS CO., LTD. come from?

All FDA import refusal data for PUNING JIANSHUN PROTECTIVE PRODUCTS 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.