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SM ENG. Co. Ltd.

✅ Low Risk

FEI: 3008912461 • Sasang, Busan • SOUTH KOREA

FEI

FEI Number

3008912461

📍

Location

Sasang, Busan

🇰🇷
🏢

Address

46 Nakdongdaero1302beon-Gil, , Sasang, Busan, South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/14/2020
Latest Refusal
4/14/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
4/14/2020
79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
118NOT LISTED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SM ENG. Co. Ltd.'s FDA import refusal history?

SM ENG. Co. Ltd. (FEI: 3008912461) has 1 FDA import refusal record(s) in our database, spanning from 4/14/2020 to 4/14/2020.

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. SM ENG. Co. Ltd.'s FEI number is 3008912461.

What types of violations has SM ENG. Co. Ltd. received?

SM ENG. Co. Ltd. has been cited for 1 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 SM ENG. Co. Ltd. come from?

All FDA import refusal data for SM ENG. 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.