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Strategic Manufacturing Company Limited

✅ Low Risk

FEI: 3009049311 • Khlong Luang, Pathum Thani • THAILAND

FEI

FEI Number

3009049311

📍

Location

Khlong Luang, Pathum Thani

🇹🇭

Country

THAILAND
🏢

Address

26/15-17 Moo 18 Thanon Phahon Yothin, , Khlong Luang, Pathum Thani, Thailand

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/12/2014
Latest Refusal
12/12/2014
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
12/12/2014
79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Strategic Manufacturing Company Limited's FDA import refusal history?

Strategic Manufacturing Company Limited (FEI: 3009049311) has 1 FDA import refusal record(s) in our database, spanning from 12/12/2014 to 12/12/2014.

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. Strategic Manufacturing Company Limited's FEI number is 3009049311.

What types of violations has Strategic Manufacturing Company Limited received?

Strategic Manufacturing Company Limited 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 Strategic Manufacturing Company Limited come from?

All FDA import refusal data for Strategic Manufacturing Company Limited 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.