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Alan Malapan

⚠️ Moderate Risk

FEI: 3005325985 • Quezon City • PHILIPPINES

FEI

FEI Number

3005325985

📍

Location

Quezon City

🇵🇭
🏢

Address

31 Pines St, , Quezon City, , Philippines

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/29/2005
Latest Refusal
10/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
10/29/2005
61PDA09GLIPIZIDE (ANTI-DIABETIC)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/29/2005
61JDA11GEMFIBROZIL (ANTI-CHOLESTEREMIC)
118NOT LISTED
San Francisco District Office (SAN-DO)
10/29/2005
62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Alan Malapan's FDA import refusal history?

Alan Malapan (FEI: 3005325985) has 3 FDA import refusal record(s) in our database, spanning from 10/29/2005 to 10/29/2005.

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. Alan Malapan's FEI number is 3005325985.

What types of violations has Alan Malapan received?

Alan Malapan 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 Alan Malapan come from?

All FDA import refusal data for Alan Malapan 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.