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NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD.

✅ Low Risk

FEI: 3008957410 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3008957410

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Renhe Suite 3 102, 61 Gaohu Road; Dev.Zone, Nanjing, Jiangsu, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
10/27/2011
Latest Refusal
10/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

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
10/27/2011
86HPPHEADLAMP, OPERATING, BATTERY-OPERATED
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)

Frequently Asked Questions

What is NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD.'s FDA import refusal history?

NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD. (FEI: 3008957410) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 10/27/2011.

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. NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD.'s FEI number is 3008957410.

What types of violations has NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD. received?

NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE 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 NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE CO., LTD. come from?

All FDA import refusal data for NANJING KEWEISI MEDICAL LIGHTING TECHNIQUE 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.