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Shijiazhuang Sail Plastic Co Ltd

⚠️ Moderate Risk

FEI: 3008494344 • Shijiazhuang, Hebei • CHINA

FEI

FEI Number

3008494344

📍

Location

Shijiazhuang, Hebei

🇨🇳

Country

CHINA
🏢

Address

Room 201 Unit 7, # 136 Shifan Street, Shijiazhuang, Hebei, China

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/24/2010
Latest Refusal
11/24/2010
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4771×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
11/24/2010
80LYZGLOVE, PATIENT EXAMINATION, VINYL
223FALSE
477HOLES
New England District Office (NWE-DO)

Frequently Asked Questions

What is Shijiazhuang Sail Plastic Co Ltd's FDA import refusal history?

Shijiazhuang Sail Plastic Co Ltd (FEI: 3008494344) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2010 to 11/24/2010.

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. Shijiazhuang Sail Plastic Co Ltd's FEI number is 3008494344.

What types of violations has Shijiazhuang Sail Plastic Co Ltd received?

Shijiazhuang Sail Plastic 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 Shijiazhuang Sail Plastic Co Ltd come from?

All FDA import refusal data for Shijiazhuang Sail Plastic 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.