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Faci Asia Pacific Pte. Ltd.

⚠️ Moderate Risk

FEI: 3003677902 • Singapore • SINGAPORE

FEI

FEI Number

3003677902

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

1 Merlimau Place, Jurong Island, Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/9/2011
Latest Refusal
8/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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
8/9/2011
55RP50CALCIUM STEARATE (PHARMACEUTIC NECESSITY - TABLET LUBRICANT)
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/9/2011
55RP50CALCIUM STEARATE (PHARMACEUTIC NECESSITY - TABLET LUBRICANT)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Faci Asia Pacific Pte. Ltd.'s FDA import refusal history?

Faci Asia Pacific Pte. Ltd. (FEI: 3003677902) has 2 FDA import refusal record(s) in our database, spanning from 8/9/2011 to 8/9/2011.

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. Faci Asia Pacific Pte. Ltd.'s FEI number is 3003677902.

What types of violations has Faci Asia Pacific Pte. Ltd. received?

Faci Asia Pacific Pte. 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 Faci Asia Pacific Pte. Ltd. come from?

All FDA import refusal data for Faci Asia Pacific 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.