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Pharmasi Instrument Company Limited

⚠️ Moderate Risk

FEI: 3008001801 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3008001801

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

No 358 Songjiangqu, , Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/15/2010
Latest Refusal
12/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

722×

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.

Refusal History

DateProductViolationsDivision
12/15/2010
56DXR41NEOMYCIN SULFATE (AMINOGLYCOSIDES)
72NEW VET DR
Minneapolis District Office (MIN-DO)
12/15/2010
62FOR03NITROFURAZONE
72NEW VET DR
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Pharmasi Instrument Company Limited's FDA import refusal history?

Pharmasi Instrument Company Limited (FEI: 3008001801) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2010 to 12/15/2010.

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. Pharmasi Instrument Company Limited's FEI number is 3008001801.

What types of violations has Pharmasi Instrument Company Limited received?

Pharmasi Instrument Company Limited 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 Pharmasi Instrument Company Limited come from?

All FDA import refusal data for Pharmasi Instrument Company Limited 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.