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CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD

⚠️ Moderate Risk

FEI: 3004407803 • Chaozhou, Guangdong • CHINA

FEI

FEI Number

3004407803

📍

Location

Chaozhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Chao'An District, Qingnanluopian, Xifengtangpu Village; Kuihu Town, Chaozhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

39.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
3/27/2015
Latest Refusal
6/16/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

2354×

NOT IMPACT

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

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.

Refusal History

DateProductViolationsDivision
3/27/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New Orleans District Office (NOL-DO)
12/9/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
235NOT IMPACT
New Orleans District Office (NOL-DO)
11/4/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New Orleans District Office (NOL-DO)
10/31/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Cincinnati District Office (CIN-DO)
10/31/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Cincinnati District Office (CIN-DO)
6/16/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD's FDA import refusal history?

CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD (FEI: 3004407803) has 6 FDA import refusal record(s) in our database, spanning from 6/16/2014 to 3/27/2015.

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. CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD's FEI number is 3004407803.

What types of violations has CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD received?

CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. 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 CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. CO., LTD come from?

All FDA import refusal data for CHAOZHOU KAI TAI (KUI HU) OPTICAL MFG. 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.