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AEC SIAM SUPPLY COMPANY LIMITED

⚠️ Moderate Risk

FEI: 3038560453 • Bangkok • THAILAND

FEI

FEI Number

3038560453

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

Soi Ramintra 21 The Fae, , Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/14/2025
Latest Refusal
7/14/2025
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
89.9×20%
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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
7/14/2025
87MOZACID, HYALURONIC, INTRAARTICULAR
118NOT LISTED
237NO PMA
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is AEC SIAM SUPPLY COMPANY LIMITED's FDA import refusal history?

AEC SIAM SUPPLY COMPANY LIMITED (FEI: 3038560453) has 1 FDA import refusal record(s) in our database, spanning from 7/14/2025 to 7/14/2025.

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. AEC SIAM SUPPLY COMPANY LIMITED's FEI number is 3038560453.

What types of violations has AEC SIAM SUPPLY COMPANY LIMITED received?

AEC SIAM SUPPLY COMPANY LIMITED 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 AEC SIAM SUPPLY COMPANY LIMITED come from?

All FDA import refusal data for AEC SIAM SUPPLY 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.