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Lakpue Drugs Inc(La Croesus Pharma Inc.)

⚠️ Moderate Risk

FEI: 3012027714 • Murphy Quezon • PHILIPPINES

FEI

FEI Number

3012027714

📍

Location

Murphy Quezon

🇵🇭
🏢

Address

74 Lhc Square Bldg 15th Ave Corner Main, , Murphy Quezon, , Philippines

Moderate Risk

FDA Import Risk Assessment

47.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
3/25/2016
Latest Refusal
3/17/2016
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

723×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/25/2016
60NRK07NANDROLONE PHENPROPIONATE (ANDROGEN)
72NEW VET DR
Los Angeles District Office (LOS-DO)
3/18/2016
54AMH16VITAMIN E (TOCOPHEROL)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/18/2016
54AMK05VITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/18/2016
60NPK07NANDROLONE PHENPROPIONATE (ANDROGEN)
72NEW VET DR
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/17/2016
60NRL04METHYLTESTOSTERONE (ANDROGEN)
72NEW VET DR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Lakpue Drugs Inc(La Croesus Pharma Inc.)'s FDA import refusal history?

Lakpue Drugs Inc(La Croesus Pharma Inc.) (FEI: 3012027714) has 5 FDA import refusal record(s) in our database, spanning from 3/17/2016 to 3/25/2016.

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. Lakpue Drugs Inc(La Croesus Pharma Inc.)'s FEI number is 3012027714.

What types of violations has Lakpue Drugs Inc(La Croesus Pharma Inc.) received?

Lakpue Drugs Inc(La Croesus Pharma Inc.) 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 Lakpue Drugs Inc(La Croesus Pharma Inc.) come from?

All FDA import refusal data for Lakpue Drugs Inc(La Croesus Pharma Inc.) 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.