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APPLIED MATERIALS SOUTH EAST ASI

⚠️ Moderate Risk

FEI: 3012401321 • Singapore • SINGAPORE

FEI

FEI Number

3012401321

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

8 Upper Changi Road North, Applied Materials Building, Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

42.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/12/2023
Latest Refusal
7/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
49.4×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
7/12/2023
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is APPLIED MATERIALS SOUTH EAST ASI's FDA import refusal history?

APPLIED MATERIALS SOUTH EAST ASI (FEI: 3012401321) has 1 FDA import refusal record(s) in our database, spanning from 7/12/2023 to 7/12/2023.

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. APPLIED MATERIALS SOUTH EAST ASI's FEI number is 3012401321.

What types of violations has APPLIED MATERIALS SOUTH EAST ASI received?

APPLIED MATERIALS SOUTH EAST ASI 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 APPLIED MATERIALS SOUTH EAST ASI come from?

All FDA import refusal data for APPLIED MATERIALS SOUTH EAST ASI 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.