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Zfadm Group (Asia) Pte Ltd.

✅ Low Risk

FEI: 3007555838 • Singapore • SINGAPORE

FEI

FEI Number

3007555838

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

120 Telok Ayer Street, , Singapore, , Singapore

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
7/8/2011
Latest Refusal
7/8/2011
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
7/8/2011
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Zfadm Group (Asia) Pte Ltd.'s FDA import refusal history?

Zfadm Group (Asia) Pte Ltd. (FEI: 3007555838) has 1 FDA import refusal record(s) in our database, spanning from 7/8/2011 to 7/8/2011.

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. Zfadm Group (Asia) Pte Ltd.'s FEI number is 3007555838.

What types of violations has Zfadm Group (Asia) Pte Ltd. received?

Zfadm Group (Asia) Pte 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 Zfadm Group (Asia) Pte Ltd. come from?

All FDA import refusal data for Zfadm Group (Asia) Pte 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.