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Lights Medical Manufacture Co Ltd

⚠️ Moderate Risk

FEI: 3005310494 • Tianjin, Tianjin • CHINA

FEI

FEI Number

3005310494

📍

Location

Tianjin, Tianjin

🇨🇳

Country

CHINA
🏢

Address

19 Quanda Lu, Wuqing, Tianjin, Tianjin, China

Moderate Risk

FDA Import Risk Assessment

31.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/1/2019
Latest Refusal
1/29/2016
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.3×10%
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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

38831×

708NODFL

The article lacks an OTC "Drug Facts" label as required by 21 CFR 201.66.

Refusal History

DateProductViolationsDivision
4/1/2019
62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
3883708NODFL
Division of Southwest Imports (DSWI)
1/29/2016
62F34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)
186INSANITARY
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Lights Medical Manufacture Co Ltd's FDA import refusal history?

Lights Medical Manufacture Co Ltd (FEI: 3005310494) has 2 FDA import refusal record(s) in our database, spanning from 1/29/2016 to 4/1/2019.

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. Lights Medical Manufacture Co Ltd's FEI number is 3005310494.

What types of violations has Lights Medical Manufacture Co Ltd received?

Lights Medical Manufacture 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 Lights Medical Manufacture Co Ltd come from?

All FDA import refusal data for Lights Medical Manufacture 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.