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Pharmosa Biopharm Inc.

⚠️ High Risk

FEI: 3033715158 • Taipei • TAIWAN

FEI

FEI Number

3033715158

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

11F., 11F.-1, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang District, Taipei, , Taiwan

High Risk

FDA Import Risk Assessment

61.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
1/20/2026
Latest Refusal
1/20/2026
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
92.0×20%
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

752×

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
1/20/2026
66SIK99VASODILATOR N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
1/20/2026
66SIK99VASODILATOR N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Pharmosa Biopharm Inc.'s FDA import refusal history?

Pharmosa Biopharm Inc. (FEI: 3033715158) has 2 FDA import refusal record(s) in our database, spanning from 1/20/2026 to 1/20/2026.

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. Pharmosa Biopharm Inc.'s FEI number is 3033715158.

What types of violations has Pharmosa Biopharm Inc. received?

Pharmosa Biopharm Inc. 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 Pharmosa Biopharm Inc. come from?

All FDA import refusal data for Pharmosa Biopharm 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.