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Chenghai Taisheng Toys Plastic Factory

⚠️ Moderate Risk

FEI: 3006086890 • Shantou, Guangdong • CHINA

FEI

FEI Number

3006086890

📍

Location

Shantou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Laimei Road, Chenghai, Shantou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/20/2009
Latest Refusal
10/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
54.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2313×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

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).

Refusal History

DateProductViolationsDivision
10/20/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)
10/20/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)
10/2/2009
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
235NOT IMPACT
341REGISTERED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Chenghai Taisheng Toys Plastic Factory's FDA import refusal history?

Chenghai Taisheng Toys Plastic Factory (FEI: 3006086890) has 3 FDA import refusal record(s) in our database, spanning from 10/2/2009 to 10/20/2009.

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. Chenghai Taisheng Toys Plastic Factory's FEI number is 3006086890.

What types of violations has Chenghai Taisheng Toys Plastic Factory received?

Chenghai Taisheng Toys Plastic Factory has been cited for 3 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 Chenghai Taisheng Toys Plastic Factory come from?

All FDA import refusal data for Chenghai Taisheng Toys Plastic Factory 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.