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Langlang Electronic Co Ltd

⚠️ Moderate Risk

FEI: 3006386852 • Zhejiang Province • CHINA

FEI

FEI Number

3006386852

📍

Location

Zhejiang Province

🇨🇳

Country

CHINA
🏢

Address

No 124-2 Xianmen Rd Xianmen, , Zhejiang Province, , China

Moderate Risk

FDA Import Risk Assessment

41.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
3
Unique Violations
3/25/2010
Latest Refusal
1/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

477×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

2785×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

1264×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
3/25/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)
3/25/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
Los Angeles District Office (LOS-DO)
3/25/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
Los Angeles District Office (LOS-DO)
2/1/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)
2/1/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)
1/29/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)
1/29/2010
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Langlang Electronic Co Ltd's FDA import refusal history?

Langlang Electronic Co Ltd (FEI: 3006386852) has 7 FDA import refusal record(s) in our database, spanning from 1/29/2010 to 3/25/2010.

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. Langlang Electronic Co Ltd's FEI number is 3006386852.

What types of violations has Langlang Electronic Co Ltd received?

Langlang Electronic Co Ltd 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 Langlang Electronic Co Ltd come from?

All FDA import refusal data for Langlang Electronic 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.