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Cheng Yi Plastic Ind. Co., Ltd.

⚠️ Moderate Risk

FEI: 1000426596 • Xiamen, Fujian • CHINA

FEI

FEI Number

1000426596

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

Pu Nan Wu Cun, Xiamen, , Xiamen, Fujian, China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/14/2013
Latest Refusal
3/14/2013
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

2311×

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.

Refusal History

DateProductViolationsDivision
3/14/2013
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Cheng Yi Plastic Ind. Co., Ltd.'s FDA import refusal history?

Cheng Yi Plastic Ind. Co., Ltd. (FEI: 1000426596) has 1 FDA import refusal record(s) in our database, spanning from 3/14/2013 to 3/14/2013.

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. Cheng Yi Plastic Ind. Co., Ltd.'s FEI number is 1000426596.

What types of violations has Cheng Yi Plastic Ind. Co., Ltd. received?

Cheng Yi Plastic Ind. 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 Cheng Yi Plastic Ind. Co., Ltd. come from?

All FDA import refusal data for Cheng Yi Plastic Ind. 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.